Volemic Resuscitation in Sepsis and Septic Shock

Sepsis Clinical Trial

Official title:

Volemic Resuscitation in Sepsis and Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02565251
• Other study ID #: FWA00022929
• Status: Recruiting
• Phase: N/A
• First received: September 1, 2015
• Last updated: December 13, 2016
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: December 2016
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Natalia Hagau, Professor
• Phone: 0742272385
• Email: hagaunatalia[@]gmail.com
• Is FDA regulated: No
• Health authority: Romania: Iuliu Hatieganu Univesity of Medicine and Pharmacy Ethics Comitee
• Study type: Interventional

Clinical Trial Summary

Severe sepsis and septic shock are among the leading causes of morbidity and mortality in patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the USA and 150000 in Europe. Recognizing the early signs of sepsis and the different stages of this condition may lower the associated morbidity and mortality.

The hemodynamic profile of the septic shock is characterized by the presence of the distributive shock, on which we can add elements from the hypovolemic and cardiogenic shocks.

The objecive of this study is to optimize the volemic resuscitation of the severe septic and of the septic shock patient using two minimally invasive methods of hemdynamic monitoring which both use the same device (Edwards Lifescience). In the same time hemodinamic data will be colected by mesuring the inferior vena cava diameter.

Description:

Severe sepsis and septic shock are among the leading causes of morbidity and mortality in patients admitted in the ICU, being responsible for approximately 200000 deaths/year in the USA and 150000 in Europe . Recognizing the early signs of sepsis and the different stages of this condition may lower the associated morbidity and mortality.

The hemodynamic profile of the septic shock is characterized by the presence of the distributive shock, on which we can add elements from the hypovolemic and cardiogenic shocks. The persistence of hypotension after adequate fluid load is the result of low vascular resistance and myocardial dysfunction and calls for certain specific correctional measures.

The diffrent hemodynamic profiles which can be found in the different stages of the septic shock and their dificult clinical identification led to the development of varoius hemodynamic monitoring techniques and devices. These techniques can be classified into invasive and minimally invasive, calibrated and uncalibrated. The major diffrences among these tecniques is the easyness of utilisation and the acuracy of the data obtained.

Inclusion Criteria: severe sepsis and septic shock (acording to the Sepsis Campaign 2013 crieria) patients with medical or surgical pathology which are admitted in the ICU unit in the first six hours after the onset of the severe sepsis/septic shock. The exclusion criteria of the patients are age less then 18 and more then 75, cardiac valvular pathology with hemodynamic importance, cardiac failure NYHA III și IV, primary or secondary pulmonary hypertension with hemodymanic impact with onset before the onset of the septic pathology,severe liver failure (Child-Pugh C), anuric renal failure, pregnant women, patient who refuse blood products adminitration, end-stage cancer.

The objecive of this study is to optimize the volemic resuscitation of the severe septic and of the septic shock patient using two minimally invasive methods of hemdynamic monitoring which both use the same device (Edwards Lifescience). In the same time hemodinamic data will be colected by mesuring the inferior vena cava diameter.

The primary outcome is the adecuacy of tissue perfusion at six hours (urinary output, blood pressure, lactate clearance, skin aspect). The secondary oucomes are duration of cardiovascular failure at the end of the 6 hours resuscitation period/ number of days, duration of respiratory failure (need of mechanical ventilation, number of days), duration of acute renal failure (need of dialysis) at ICU discharge/10/30/60 days, duration of ICU stay and in hospital stay, discharge status at 60 days (not discharged ,discharge to another acute care hospital, discharged to nursing home, discharged home ,other or unknown and all cause mortality at 60 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria: sepsis and septic shock (acording to the Sepsis Campaign 2016 crieria) patients with medical or surgical pathology which are admitted in the ICU unit in the first 12 hours after the onset of the sepsis/septic shock

Exclusion Criteria:

age less then 18 and more then 85 cardiac valvular pathology with hemodynamic importance cardiac failure NYHA IV primary or secondary pulmonary hypertension with hemodymanic impact with onset before the onset of the septic pathology Severe liver failure (Child-Pugh C) Anuric renal failure Pregnant women Patient who refuse blood products adminitration End-stage cancer

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodynamic Instability
• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

Device:
• Flotrac/Ev1000
Hemodynamic resusucitation guided by the data obtained from the monitorisation with Flotrac/Ev1000 device in the first two hours
• Standard ICU monitorisation
Hemodynamic resusucitation guided by the data obtained from ICU standard hemodynamic monitoring (BP, CVP) in the first 2 hours
• VolumeView/Ev1000
Hemodynamic resusucitation guided by the data obtained from the monitorisation with VolumeView/Ev1000 device in the next four hours

Locations

Country	Name	City	State
Romania	Cluj County Emenrgency Hospital	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

References & Publications (11)

Antonelli M, Levy M, Andrews PJ, Chastre J, Hudson LD, Manthous C, Meduri GU, Moreno RP, Putensen C, Stewart T, Torres A. Hemodynamic monitoring in shock and implications for management. International Consensus Conference, Paris, France, 27-28 April 2006. — View Citation

ARISE Investigators.; ANZICS Clinical Trials Group., Peake SL, Delaney A, Bailey M, Bellomo R, Cameron PA, Cooper DJ, Higgins AM, Holdgate A, Howe BD, Webb SA, Williams P. Goal-directed resuscitation for patients with early septic shock. N Engl J Med. 201 — View Citation

Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pr — View Citation

Bakker J, Nijsten MW, Jansen TC. Clinical use of lactate monitoring in critically ill patients. Ann Intensive Care. 2013 May 10;3(1):12. doi: 10.1186/2110-5820-3-12. — View Citation

Cecconi M, Arulkumaran N, Kilic J, Ebm C, Rhodes A. Update on hemodynamic monitoring and management in septic patients. Minerva Anestesiol. 2014 Jun;80(6):701-11. Review. — View Citation

Cecconi M, Hofer C, Della Rocca G, Grounds RM, Rhodes A. Assessing agreement in cardiac output monitoring validation studies. J Cardiothorac Vasc Anesth. 2010 Aug;24(4):741; author reply 741-2. doi: 10.1053/j.jvca.2009.11.008. — View Citation

Lilly CM. The ProCESS trial--a new era of sepsis management. N Engl J Med. 2014 May 1;370(18):1750-1. doi: 10.1056/NEJMe1402564. — View Citation

Marqué S, Gros A, Chimot L, Gacouin A, Lavoué S, Camus C, Le Tulzo Y. Cardiac output monitoring in septic shock: evaluation of the third-generation Flotrac-Vigileo. J Clin Monit Comput. 2013 Jun;27(3):273-9. doi: 10.1007/s10877-013-9431-z. — View Citation

Monnet X, Anguel N, Naudin B, Jabot J, Richard C, Teboul JL. Arterial pressure-based cardiac output in septic patients: different accuracy of pulse contour and uncalibrated pressure waveform devices. Crit Care. 2010;14(3):R109. doi: 10.1186/cc9058. — View Citation

Mouncey PR, Osborn TM, Power GS, Harrison DA, Sadique MZ, Grieve RD, Jahan R, Harvey SE, Bell D, Bion JF, Coats TJ, Singer M, Young JD, Rowan KM; ProMISe Trial Investigators.. Trial of early, goal-directed resuscitation for septic shock. N Engl J Med. 201 — View Citation

Russell JA. Is there a good MAP for septic shock? N Engl J Med. 2014 Apr 24;370(17):1649-51. doi: 10.1056/NEJMe1402066. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue perfusion at six hours (composite)	Tissue perfusion at six hours: urinary output, blood pressure, lactate clearance, skin aspect	six hours	No
Secondary	Duration of cardiovascular failure	need of vasopressor support: at the end of the 6 hours resuscitation period and one, two, six and twelve days	at the end of the 6 hours resuscitation period and one, two, six and twelve days	No
Secondary	Duration of respiratory failure	respiratory failure at oane day, two days, six days and twelve days	respiratory failure at oane day, two days, six days and twelve days	No
Secondary	Duration of acute renal failure	Duration of acute renal failure (need of dialysis) at 5 days, at 10 days, at 30 days and at 60 days	at 5 days, at 10 days, at 30 days and at 60 days	No
Secondary	Duration of ICU stay and in hospital stay	Duration of ICU stay and in hospital stay	status at 5 days, at 10 days, at 30 days and at 60 days	No
Secondary	Discharge status at 60 days	Discharge status at 60 days:Not discharged ,Discharge to another acute care hospital,Discharged to nursing home,Discharged home ,Other or unknown	at 60 days	No
Secondary	all cause mortality at 60 days	all cause mortality at 60 days	60 days	No