Hemodynamic Resuscitation and Monitoring in Early Sepsis

Septic Shock Clinical Trial

— HERMES  

Official title:

Hemodynamic Resuscitation and Monitoring in Early Sepsis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04143035
• Other study ID #: 3364
• Status: Active, not recruiting
• Start date: October 22, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: October 2022
• Source: Tata Memorial Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

"Hemodynamic Resuscitation and Monitoring in Early Sepsis (HERMES Study)" involves recording of patient's medical data related to that has been collected as part of his/her routine medical care in ICU.

Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice. The investigators would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, Investigator would like to identify factors associated with improved outcomes and achieving the goals of the sepsis bundles in one, three and six hours.

The objectives of the study is to capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patients presenting with early sepsis and hypotension to Indian ICUs

Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients in a maximum time window of 60 days. A convenience sample of minimum 500 patients presenting to ICU with suspected sepsis and hypotension will be taken.

Each Centre will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled.

This is an ISCCM(Indian Society of Critical Care Medicine) Research Committee funded study. The ISCCM will fund the Principal Investigator for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication. No funding will be given to the investigators from the various participating centers for contributing data.

Description:

INTRODUCTION Septic shock is the most commonly occurring of all types of shock.The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) defines septic shock as a subset of sepsis in which particularly profound circulatory, cellular, and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone. Patients with septic shock can be clinically identified by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia. This combination is associated with hospital mortality rates greater than 40%.

The "sepsis bundle" has been central to the implementation of the Surviving Sepsis Campaign (SSC) from the first publication of its evidence-based guidelines in 2004 through subsequent editions. Developed separately from the guidelines publication by the SSC, the bundles have been the cornerstone of sepsis quality improvement since 2005. An updated version was published in 2016 "Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock". There is compelling nature of the evidence in the literature which demonstrates an association between compliance with bundles and improved survival in patients with sepsis and septic shock. This has led to the adoption of the SSC measures by the National Quality Forum (NQF) and other departments. The important relationship between the bundles and survival was confirmed in a publication from this initiative.

The Surviving Sepsis Campaign released an updated one-hour sepsis bundle, which combines recommendations listed in the three-hour and six-hour bundles. This includes 5 elements: 1. measuring lactate levels 2. obtaining blood cultures before administering antibiotics 3. administering broad-spectrum antibiotics 4. fluid resuscitation for hypotension or lactate level ≥ 4 mmol/L and 5. use of vasopressors for hypotensive during or after fluid resuscitation to maintain MAP ≥ 65 mm Hg.

Presently there is no data from Indian ICUs on the way patients in early sepsis are resuscitated and monitored. There may exist a wide variation in clinical practice.The Investigator would like to conduct an observational study in various levels of Indian ICUs, to prospectively collect data on adult patients admitted to ICU with early sepsis in a 60-day window period. Investigator would like to study the hemodynamic resuscitation and monitoring performed in these patients. In addition, investigator would like to identify factors associated with improved outcomes and fulfilling the goals of the one hour SSC bundles within one, three and six hours in patients with sepsis and septic shock.

OBJECTIVES

1. To capture the patient characteristics and hemodynamic resuscitation and monitoring practices in patient presenting with early sepsis and hypotension to Indian ICUs

2. To determine various factors associated with improved survival in patients with septic shock

3. To determine factors associated with achieving the 1 hour, 3 hour and 6-hour resuscitation goals of the sepsis bundle in patients with septic shock

METHODS Study design- Prospective observational multi-center national cohort study.

Patient Recruitment

ISCCM members across India will be contacted to register their ICUs in the study, through emails sent from the ISCCM Research committee. Repeated emails will be sent over a two-month period. Hospitals with more than one ICU can enroll each of their ICUs separately. Each ICU will need to contribute a minimum of 10 adult patients with sepsis and hypotension in a 60 day window period.

Each center will designate a maximum of two local coordinators (PI and Co-PI) who will provide scientific and structural leadership in their centers. They will ensure that all local necessary ethical and regulatory approvals are obtained before the start of patient inclusion.

Local coordinators will guarantee the integrity of data collection and ensure timely completion of the case record forms. Each center will select a 60 day window period for patient recruitment. The start date may be anytime any time between 1st August to 15th October 2019. Therefore, the recruitment window period will end for a respective centre, anytime between 30th September and 14th December 2019, depending on the start date. All consecutive patients in the 60-day period will be screened and those eligible will be enrolled.

Data Collection

1. There will be no direct patient contact or intervention. Local coordinators will guarantee the integrity of data collection and ensure timely completion of CRFs (case record forms). Date related to the following will be collected prospectively from the charts:

2. Patient demographic data e.g. age, sex, comorbidities, likely source of sepsis

3. Total number of ICU patients, patients with sepsis and septic shock admitted to the ICU in the 60 days period

4. Patient clinical examination findings and severity of illness

5. Details of hemodynamic monitoring and other systemic monitoring and therapy performed in ICU e.g. fluid bolus, vasopressor agents, monitoring devices used, hemodynamic variables measured, mechanical ventilation, dialysis etc. in the first 3 days of ICU admission

6. Antibiotics administered and details of microbiology examinations

7. Adjunct therapies initiated for sepsis

8. ICU, hospital and 28-day mortality

Sample size The primary endpoint of study was to determine the incidence of ICU mortality in patients with septic shock admitted to Indian ICUs. The sample size calculation was done on the basis of INDICAPS I(Indian Intensive Care Case Mix and Practice Patterns Study-I) Study data (IJCCM April 2016). In this study the ICU mortality incidence was found to be 45% in patients with septic shock. Assuming the incidence rate found in this study, a sample size of 401 produces a two-sided 95% confidence interval with a width equal to 0.100 when the sample proportion is 0.450. Sample size calculation was done using PASS software. To account for attrition, Investigator will take a sample size of at least 450 patients. Investigator plan to recruit 50 -100 centers nationwide. Each center will be asked to collect data from at least 10 patients, hence investigator should be able to meet this target of >450 patients.

Statistical analysis The primary objective of the study is to determine the patient characteristics and hemodynamic resuscitation and monitoring practices in patient presenting with early sepsis and hypotension to Indian ICUs which will be analyzed using descriptive statistics. To determine various factors associated with improved survival in patients with septic shock investigator will use the Fisher's exact test or Pearson's χ2 test. Univariable and Multivariable logistic regression models will be developed to assess the independent effects on ICU mortality. To determine factors associated with achieving the 1 hour SSC Sepsis resuscitation bundle in 1 hour, 3 hours and 6-hours in patients with sepsis and septic shock will be assessed by Fisher's exact test or Pearson's χ2 test. Univariable and Multivariable logistic regression models will be developed to assess the independent effects on ICU mortality of the 1 hour, 3 hour and 6-hour resuscitation goals of the sepsis bundle in patients with sepsis and septic shock. The overall performance of the internally validated model will be assessed using Nagelkerke's R2 (R squared in logistic regression). The higher Nagelkerke's R2, the greater the strength of the model. The ability of the models to identify ICU mortality will be quantified as the area under the receiver operating characteristic curve (AUC). The AUC ranges from 50% to 100%, indicating no discriminative capacity to perfect discriminative capacity. The agreement between predicted probabilities and observed frequencies of the outcome will be assessed by visually inspecting the calibration plot. Last, the Hosmer and Lemeshow goodness-of-fit statistic will be computed as a quantitative measure of accuracy. A high outcome of this statistic is related to a low p-value, which indicates a poor fit. All analysis will two sided, and significance will set at a p-value of 0.05. Statistical analyses will be performed using SPSS (the statistical package for social sciences) IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, New York: IBM Corp and R studio (version 1.2).

INSTITUTIONAL ETHICS COMMITTEE (IEC) APPROVAL The local hospital investigators should ensure that all necessary local ethical and regulatory approvals are obtained if required, before the start of the study in their institution.

CONSENT FOR DATA COLLECTION This is an observational study and involves capture of data from the patient charts. There is no direct patient contact or intervention, hence written, informed consent is not mandatory. However, if required by the institution, consent may be taken from the patients legally accepted representative (LAR). Sample short consent forms for patient data capture will be provided by the PI in English, Hindi and Marathi. This may be translated in various regional languages as required by the local investigator

STUDY FUNDING This is an ISCCM Research Committee funded study. The ISCCM will fund the Principal Investigator institution for all expenses related software development, website hosting, secretarial assistance and miscellaneous expenses related to the conduct of the study, data analysis and publication (against actual bills). No funding will be given to the investigators from the various participating centres for contributing data.

DATA STORAGE AND OWNERSHIP The Principal Investigator will have ownership of the data. The data will be stored in the Principal Investigators department at Tata Memorial Hospital, Mumbai for 10 years.

PUBLICATION AND AUTHORSHIP POLICY The main results of study will be published in a peer-reviewed medical journal. Authorship policy will follow the International Committee of Medical Journal Editors (ICMJE) recommendations. Authorship will be considered based on contributions the study design and protocol development, recruitment of patients, data acquisition and cleaning, analysis and interpretation of the data, manuscript writing and final approval of the version to be published and agreement to be accountable for all aspects of the work, in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Steering Committee - Members of the Steering Committee will include 7 members from the Principal Investigators center and 8 -10 experts from across the country. They will be involved and provide active guidance from inception till publication of the study.

Writing committee and main author list - Members of the steering committee and Principal Investigator from the top 3 centers with highest number of patient recruitment.

The Principal Investigator and Co-Principal Investigator from each participating ICU will be in the list of study collaborators and their names will be in the publication. The names of all the investigators will be indexed in PubMed depending on the journal policy.

SECONDARY ANALYSES After publication of the primary results, on request, the pooled dataset will be available for investigators for secondary analysis, after judgment and approval of scientific quality and validity by the steering committee. Before submission, the final version of all manuscripts related to the study dataset must be approved by the steering committee. The members of the writing committee will be authors of the publications derived from the study dataset.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

1. Adult patients (= 18 years old)

2. Presenting to ICU with suspected sepsis

3. Presence of hypotension (Systolic BP = 90 mmHg / Mean arterial pressure (MAP) = 65mmhg or patient with Systolic BP > 90 mmHg / MAP >65mmHg on vasopressor.

Exclusion Criteria

1. Patient likely to be in shock due to reason other than sepsis (e.g. cardiogenic or hemorrhagic shock)

2. Decision taken for not intubating / ventilating /aggressive resuscitation prior to ICU admission

3. Patient transferred from another ICU OR another hospital (only if stay >7 days)

Related Conditions & MeSH terms

• Septic Shock
• Shock, Septic

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
India	Nayati Hospital - Trauma & Acute Care Centre	Agra
India	Purushottam das Savitri Devi Cancer center	Agra
India	Pushpanjali Hospital	Agra
India	Rainbow Hospitals	Agra
India	Narayana Multispeciality Hospital	Ahmedabad
India	Sterling hospital	Ahmedabad
India	Zydus Hospitals Ahmedabad	Ahmedabad
India	Saideep Healthcare and Research Pvt Ltd	Ahmednagar
India	J N Medical College & Hospital	Aligarh
India	Ohm Trauma centre and critical care	Aligarh
India	Emc hospital	Amritsar
India	Fortis Escorts Hospital Amritsar	Amritsar
India	Kamalnayan Bajaj hospital	Aurangabad
India	Mgm Medical College Hospital and Medical Centre Research Institute(McRi)	Aurangabad
India	Oriion Citicare Superspeciality Hospital	Aurangabad
India	Shraddha hospital and critical care center	Aurangabad
India	Bhagwan Mahaveer Jain Hospital	Bangalore
India	Columbiaasia Referral Hospital, Yeshwantpur	Bangalore
India	Cytecare Cancer Hospital	Bangalore
India	Health care Global (HCG)	Bangalore
India	Shifaa hospital	Bangalore
India	Shri Ram Murti Smarak Institute of Medical Sciences	Bareilly
India	Geeta Hospital and research centre	Barnagar
India	Aster R V Hospital	Bengaluru
India	Manipal hospital	Bengaluru
India	Mazumdar Shaw Medical Center	Bengaluru
India	Regal Hospital	Bengaluru
India	St John's Medical College Hospital	Bengaluru
India	Vydehi Institute of Medical Sciences and Research Centre	Bengaluru
India	Apollo Hospitals	Bhubaneshwar
India	Amri Hospital	Bhubaneswar
India	Amri hospital ICU -1	Bhubaneswar
India	AMRI Hospitals	Bhubaneswar
India	Apollo Hospital	Bhubaneswar
India	Apollo Hospitals	Bhubaneswar
India	BR Life Kalinga Hispital	Bhubaneswar
India	Care Hospital	Bhubaneswar
India	Care Hospitals	Bhubaneswar
India	Gudage Hospital	Bidar
India	Ayush Hospital	Bijapur
India	Apollo Hospital	Bilaspur
India	Apollo Hospital Icu-1	Bilaspur
India	K.M.Memorial hospital and research centre	Bokaro
India	PGIMER	Chandigarh
India	Apollo Hospitals Enterprise limited	Chennai
India	Billroth hospital	Chennai
India	Dr.Rela Institute and Medical Centre	Chennai
India	Mgm Healthcare Ltd.	Chennai
India	Sri Ramachandra Hospital	Chennai
India	Sri Ramchandra Medical Centre	Chennai
India	MOSC Medical College	Cochin
India	Kovai Medical Center Hospital and Research	Coimbatore
India	Royal Care Super Speciality Hospital	Coimbatore
India	Ashwini Hospital	Cuttack
India	Goodluck Hospital	Cuttack
India	SCB Medical College	Cuttack
India	Scb Medical College and Hospital	Cuttack
India	Paras Global Hospital	Darbhanga
India	Dharmshila Narayana Superspeciality Hospital	Delhi
India	Dr. Ram Manohar Lohia Hospital	Delhi
India	Dr. Ram Manohar Lohia Hospital ,New Delhi	Delhi
India	kailash Hospital and heart Institute	Delhi
India	Pushpawati Singhania Research Institute	Delhi
India	Sir Ganga Ram Hospital	Delhi
India	BKL Walawalkar Hospital	Dervan
India	Muthukrishnan Periasamy	Erode
India	Qrg Healthcity	Faridabad
India	Sarvodaya hospital and research centre	Faridabad	Uttar Pradesh
India	Yashoda super specialty hospital, kaushambi	Ghaziabad
India	City Hospital	Gorakhpur
India	Dr.Ramesh Cardiac and Multiplicity PVT LTD	Guntur
India	GBR super speciality hospitals	Guntur
India	Lalitha Super Specialities Hospital	Guntur
India	Samistha Hospital and Research Institute	Guntur
India	Medanta Medicity	Gurgaon
India	Medanta the medicity	Gurgaon
India	Medanta the medicity hospital	Gurgaon
India	Narayana Super Specialty Hospital	Gurgaon
India	VPS Medeor Hospital	Gurgaon
India	Apollo hospitals	Guwahati
India	Apollo Hospitals Guwahati	Guwahati
India	Ayursundra Superspecialty hospital	Guwahati
India	Dispur Hospitals pvt Ltd	Guwahati
India	Gnrc Hospitas, Dispur	Guwahati
India	Health City	Guwahati
India	Nemcare Hospital	Guwahati
India	Santhi Hospital	Hosur
India	Aig Hospitals, Gachibowli	Hyderabad
India	Apollo health city	Hyderabad
India	Apollo Health City ICU-1	Hyderabad
India	Aware Gleneagles Global Hospital	Hyderabad
India	Care hospital and institute of medical sciences	Hyderabad
India	Care hospitals banjara	Hyderabad
India	CENTURY hospital	Hyderabad
India	Century Super Speciality Hospital	Hyderabad
India	Continental Hospitals	Hyderabad
India	Gleneagles Global Hospital	Hyderabad
India	Krishna Institute of Medical Sciences	Hyderabad
India	Rainbow childrnes hospital	Hyderabad
India	South Central Railway Hospital	Hyderabad
India	South Central Railway Hospital ICU-1	Hyderabad
India	Virinchi Hospital	Hyderabad
India	Yashoda Hospital	Hyderabad
India	Choithram hospital	Indore
India	Anant Institute of Medical Sciences	Jabalpur	Madhya Pradesh
India	Dodeja Hospital	Jabalpur
India	Apex Hospital	Jaipur
India	Eternal Hospital	Jaipur	Rajasthan
India	Manipal hospital	Jaipur
India	Shubh Hospital	Jaipur
India	Shrimann Superspeciality Hospital	Jalandhar
India	shrimann superspeciality hospital ICU-1	Jalandhar
India	Kripa Critical Care and Trauma Centre	Jalgaon
India	Smvd Narayana Superspeciality Hospital	Jammu
India	Tata Main Hospital	Jamshedpur
India	All India Institute of Medical Sciences, jodhpur	Jodhpur
India	Ved Hospital	Kalyan
India	Abha superspeciality hospital	Kanpur
India	Fortune Hospital	Kanpur	Uttar Pradesh
India	Regency hospital ltd tower 1	Kanpur
India	Shree Krishna Hospital	Karamsad
India	Shree krishna hospital ICU-1	Karamsad
India	Sankalpa hospital	Khammam
India	Amrita institute of Medical Sciences	Kochi
India	AMRI Hospital Mukundapur	Kolkata
India	AMRI Hospital, DHAKURIA	Kolkata
India	Apollo Gleneagles Hospital	Kolkata
India	Bellevue Clinic	Kolkata
India	Fortis Hospital Anandapur	Kolkata
India	Institute of Neurosciences Kolkata	Kolkata
India	Medica Superspecialty Hospital	Kolkata
India	Peerless Hospitex Hospital and Research Center Limited	Kolkata
India	Tata Medical Center	Kolkata
India	Travancore medical college,medicity	Kollam
India	Govt.Medical college	Kottayam
India	King George's Medical University	Lucknow
India	Christian Medical College	Ludhiana
India	Dayanand Medical College and Hospital	Ludhiyana	Panjab
India	Apollo speciality hospital	Madurai
India	Kasturba medical college, Manipal	Manipala
India	Nayati medicity hospital	Mathura
India	Manglam Hosp	Meerut
India	Metro Hospital and heart Institute	Meerut
India	Cheema Medical Complex	Mohali
India	Fortis Hospital	Mohali
India	MAX Superspecialty Hospital	Mohali
India	Asian Cancer Institute	Mumbai
India	Bhatia Hospital	Mumbai
India	Breach Candy Hospital Trust	Mumbai	Maharashtra
India	Dr L H HIRANANDANI HOSPITAL	Mumbai
India	Fortis hiranandani hospital	Mumbai
India	Fortis Hospital Mulund	Mumbai
India	Fortis hospitals	Mumbai
India	Global Hospital	Mumbai
India	Global Hospital,Parel	Mumbai
India	Holy Family Hospital	Mumbai
India	Nanavati Hospital	Mumbai
India	Nanavati Hospital Icu-1	Mumbai
India	Nanavati hospital ICU-2	Mumbai
India	Nanavati Hospital Icu-3	Mumbai
India	Nanavati hosptial	Mumbai
India	Pd Hinduja National Hospital and Mrc	Mumbai
India	s.l.Rahej hospital- a fortis associate	Mumbai
India	Sir H N Reliance Foundation Hospital	Mumbai
India	Suasth Health Care	Mumbai
India	Tata Memorial Hospital (FICU)	Mumbai
India	Tata Memorial Hospital (SICU)	Mumbai
India	Wockhardt Hopsital South Mumbai	Mumbai
India	Cauvery Heart and multispeciality hospital	Mysore
India	Jss Hospital	Mysore
India	Gopalagowda Shanthaveri Memorial Hospital	Mysuru
India	Aditya Hospital	Nagpur
India	Criticare Hospital and Research Institute	Nagpur	Maharashtra
India	Dew medicare and Trinity Hospital	Nagpur
India	Dr V E Tambe Critical Care	Nagpur
India	Meditrina Institute Of Medical Scineces	Nagpur
India	Orange City Hospital And Research Institute	Nagpur
India	Rahate Surgical Hospital and Iccu	Nagpur
India	Shree Hospital and Critical Care Centre	Nagpur
India	Apollo Hospitals	Nashik
India	National Burns Centre	Navi Mumbai
India	Narayana Medical College	Nellore
India	Narayana Medical College Icu-1	Nellore
India	Simhapuri Hospital	Nellore,
India	Batra Hospital	New Delhi
India	Batra Hospital & Medical Research Center	New Delhi
India	BLK hospital	New Delhi
India	Blk Superspeciality Hospital	New Delhi
India	Fortis Escorts Heart Institute	New Delhi
India	Fortis Hospital, Shalimar Bagh	New Delhi
India	GB Pant Institute of Post Graduate Medical Education & Research	New Delhi
India	Indraprastha apollo hospitals	New Delhi
India	Indraprastha Apollo Hospitals ICU-1	New Delhi
India	Max Super Specialty Hospital Patparganj	New Delhi
India	Northern railway central hospital	New Delhi
India	Sri Balaji Action Medical Institute	New Delhi
India	Sri balaji action medical institute ICU-1	New Delhi
India	Venkateshwar Hospital	New Delhi
India	Fortis Hospital	Noida
India	Promhex Multispeciality Hospital	Noida
India	Ojas hospital	Panchkula
India	AIIMS Patna	Patna	Bihar
India	All india institute of medical sciences	Patna	Bihar
India	All India Institute of Medical Sciences Patna	Patna
India	Indira Gandhi Institute of Medical Sciences	Patna
India	Prabhat Kumar	Patna
India	Bharati Vidyapeeth Deemed university and Medical College Hospital	Pune
India	Columbia Asia hospital	Pune
India	Galaxy care hospital	Pune	Maharashtra
India	Jupiter Hospital	Pune
India	Niramaya Hoapital	Pune
India	Ruby Hall Clinic Icu-1	Pune
India	Ruby Hall Clinic ICU-2	Pune
India	Sanjeevan Hospital	Pune	Maharashtra
India	Vishwaraj Hospital & Research Centre	Pune
India	Vishwaraj Hospital& Research Center	Pune
India	Om Hospital	Raipur
India	Pt. J. N. M. Medical College	Raipur
India	Ramskrishna care hospital	Raipur
India	Shree Narayana Hospital	Raipur
India	Genesis Multispeciality Hospital	Rajkot
India	Shree Giriraj Multispeciality hospital	Rajkot
India	Shree Giriraj Multispecialty Hospital	Rajkot
India	Sterling Hospital, Rajkot (A Division of Sterling Addlife India Private Limited)	Rajkot
India	Synergy superspeciality hospital	Rajkot
India	Bhagwan Mahavir Medica Superspecialty Hospital	Ranchi
India	Sagarshree Hospital	Sagar
India	Sagarshree Hospital	Sagar
India	Abdul Waheed Mir	Srinagar
India	Sheri Kashmir Institute of Medical Sciences	Srinagar
India	Kiran Hospital	Surat
India	Shree Sardar Smarak Hospital	Surat
India	Believers Church Medical College and Hospital	Tiruvalla
India	Trichy Srm Medical College Hospital & Research Centre	Trichinopoly
India	Kerala Institute of Medical sciences	Trivandrum
India	Siddaganga hospital and research centre	Tumuluru
India	Pims	Udaipur	Rajasthan
India	Kamlesh Kanwar Shekhawat	Udaipur,	Rajasthan
India	Sterling Hospitals	Vadodara
India	Homi Bhaba Cancer Hospital & Pandit Madan Mohan Malviya Cancer Centre,Tata Memorial Centre,Varanasi	Varanasi
India	S S Hospital BHU VARANASI	Varanasi
India	Sir Sundar lal Hospital, IMS, BHU, Varanasi	Varanasi	Uttar Pradesh
India	Sir Sunderlal Hospital	Varanasi	Uttar Pradesh
India	Christian Medical College	Vellore
India	Nagarjuna hospital	Vijayawada
India	St Ann Hospital	Visakhapatnam
India	Samraksha super speciality	Warangal
India	Arnam Hospital	Wardha

Sponsors (2)

Lead Sponsor	Collaborator
Tata Memorial Centre	Indian Society of Critical Care Medicine

Country where clinical trial is conducted

India, 

References & Publications (17)

Damiani E, Donati A, Serafini G, Rinaldi L, Adrario E, Pelaia P, Busani S, Girardis M. Effect of performance improvement programs on compliance with sepsis bundles and mortality: a systematic review and meta-analysis of observational studies. PLoS One. 2015 May 6;10(5):e0125827. doi: 10.1371/journal.pone.0125827. eCollection 2015. Review. — View Citation

Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Intensive Care Med. 2004 Apr;30(4):536-55. Epub 2004 Mar 3. — View Citation

Dellinger RP, Carlet JM, Masur H, Gerlach H, Calandra T, Cohen J, Gea-Banacloche J, Keh D, Marshall JC, Parker MM, Ramsay G, Zimmerman JL, Vincent JL, Levy MM; Surviving Sepsis Campaign Management Guidelines Committee. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004 Mar;32(3):858-73. Review. Erratum in: Crit Care Med. 2004 Jun;32(6):1448. Dosage error in article text. Crit Care Med. 2004 Oct;32(10):2169-70. — View Citation

Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Intensive Care Med. 2008 Jan;34(1):17-60. Epub 2007 Dec 4. Erratum in: Intensive Care Med. 2008 Apr;34(4):783-5. — View Citation

Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. Erratum in: Crit Care Med. 2008 Apr;36(4):1394-6. — View Citation

Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb S, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including The Pediatric Subgroup. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock, 2012. Intensive Care Med. 2013 Feb;39(2):165-228. doi: 10.1007/s00134-012-2769-8. Epub 2013 Jan 30. — View Citation

Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af. — View Citation

Levy MM, Dellinger RP, Townsend SR, Linde-Zwirble WT, Marshall JC, Bion J, Schorr C, Artigas A, Ramsay G, Beale R, Parker MM, Gerlach H, Reinhart K, Silva E, Harvey M, Regan S, Angus DC; Surviving Sepsis Campaign. The Surviving Sepsis Campaign: results of an international guideline-based performance improvement program targeting severe sepsis. Crit Care Med. 2010 Feb;38(2):367-74. doi: 10.1097/CCM.0b013e3181cb0cdc. — View Citation

Levy MM, Evans LE, Rhodes A. The Surviving Sepsis Campaign Bundle: 2018 update. Intensive Care Med. 2018 Jun;44(6):925-928. doi: 10.1007/s00134-018-5085-0. Epub 2018 Apr 19. — View Citation

Levy MM, Pronovost PJ, Dellinger RP, Townsend S, Resar RK, Clemmer TP, Ramsay G. Sepsis change bundles: converting guidelines into meaningful change in behavior and clinical outcome. Crit Care Med. 2004 Nov;32(11 Suppl):S595-7. — View Citation

Levy MM, Rhodes A, Phillips GS, Townsend SR, Schorr CA, Beale R, Osborn T, Lemeshow S, Chiche JD, Artigas A, Dellinger RP. Surviving Sepsis Campaign: association between performance metrics and outcomes in a 7.5-year study. Crit Care Med. 2015 Jan;43(1):3-12. doi: 10.1097/CCM.0000000000000723. — View Citation

Liu VX, Morehouse JW, Marelich GP, Soule J, Russell T, Skeath M, Adams C, Escobar GJ, Whippy A. Multicenter Implementation of a Treatment Bundle for Patients with Sepsis and Intermediate Lactate Values. Am J Respir Crit Care Med. 2016 Jun 1;193(11):1264-70. doi: 10.1164/rccm.201507-1489OC. — View Citation

Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255. — View Citation

Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Intensive Care Med. 2017 Mar;43(3):304-377. doi: 10.1007/s00134-017-4683-6. Epub 2017 Jan 18. — View Citation

Rhodes A, Phillips G, Beale R, Cecconi M, Chiche JD, De Backer D, Divatia J, Du B, Evans L, Ferrer R, Girardis M, Koulenti D, Machado F, Simpson SQ, Tan CC, Wittebole X, Levy M. The Surviving Sepsis Campaign bundles and outcome: results from the International Multicentre Prevalence Study on Sepsis (the IMPreSS study). Intensive Care Med. 2015 Sep;41(9):1620-8. doi: 10.1007/s00134-015-3906-y. Epub 2015 Jun 25. — View Citation

Seymour CW, Gesten F, Prescott HC, Friedrich ME, Iwashyna TJ, Phillips GS, Lemeshow S, Osborn T, Terry KM, Levy MM. Time to Treatment and Mortality during Mandated Emergency Care for Sepsis. N Engl J Med. 2017 Jun 8;376(23):2235-2244. doi: 10.1056/NEJMoa1703058. Epub 2017 May 21. — View Citation

Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU Mortality	Overall ICU Mortality due to septic shock with hypotension	throughout ICU stay till discharge (up to 2 months)
Primary	Completing the elements of the one hour SSC sepsis bundle in one 1 hour	Identify factors associated with improved outcomes and fulfilling the goals of the one hour Surviving Sepsis Campaign (SSC) bundles within one, three and six hours in patients with sepsis and septic shock and to identify compliance with the one hour SSC bundle guidelines The Surviving Sepsis Campaign released an updated one-hour sepsis bundle, which combines recommendations listed in the three-hour and six-hour bundles. This includes 5 elements: 1. measuring lactate levels 2. obtaining blood cultures before administering antibiotics 3. administering broad-spectrum antibiotics 4. fluid resuscitation for hypotension or lactate level = 4 mmol/L and 5. use of vasopressors for hypotensive during or after fluid resuscitation to maintain MAP = 65 mm Hg	1 hour after admission upto 60 days from the study start date in respective study site (60 days)
Secondary	Hospital mortality	Over all mortality during the hospital stay	throughout the hospital stay till discharge in the respective study site (up to 3 months)
Secondary	28-day mortality	Over all mortality from ICU admission day to till 28 day	From ICU admission to 28 days in the respective study site (up to 3 months)
Secondary	Completing the elements of the one hour SSC sepsis bundle in one, three and six hours	Identify factors associated with improved outcomes and fulfilling the goals of the one hour Surviving Sepsis Campaign (SSC) bundles within one, three and six hours in patients with sepsis and septic shock and to identify compliance with the one hour, three hour and six hour SSC bundle guidelines The Surviving Sepsis Campaign released an updated one-hour sepsis bundle, which combines recommendations listed in the three-hour and six-hour bundles. This includes 5 elements: 1. measuring lactate levels 2. obtaining blood cultures before administering antibiotics 3. administering broad-spectrum antibiotics 4. fluid resuscitation for hypotension or lactate level = 4 mmol/L and 5. use of vasopressors for hypotensive during or after fluid resuscitation to maintain MAP = 65 mm Hg	1 hour, 3 hour and six hour after admission upto 60 days from the study start date in the respective study site (60 days )

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