Effect of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg in Septic Shock Patients

Septic Shock Clinical Trial

Official title:

Effectiveness of Fluid Deresuscitation With Central Venous Pressure Target 0-4 mmHg on Capillary Perfusion Density, Acute Kidney Injury Stage, Cardiac Index, and the Intensive Care Unit Length of Stay in Septic Shock Patients After Resuscitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04156451
• Other study ID #: IndonesiaUAnes040
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: October 2020
• Source: Indonesia University
• Contact: Dita Aditianingsih, M.D, Ph.D
• Phone: +628151819244
• Email: ditaaditiaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A scientific research to prove the safety and effectiveness of TVS 0 - 4 mmHg as a target of resuscitation using furosemide, to improve Perfused Vessel Density (PVD) > 25 mm / mm2, AKI stage (based on KDIGO criteria), CI > 2.5 cc / min / m2 , prevent the incidence of intubation, reduce the duration of ventilator use <120 hours and reduce the length of ICU stay in patients with septic shock after resuscitation

Description:

The study aims to evaluate the effectiveness of deresuscitation with target CVP 0 - 4 mmHg on septic shock patients in the ICU on capillary perfusion density, AKI stage (based on KDIGO criteria), the incidence of intubation, duration of use of mechanical ventilation, and length of stay in the ICU which can reduce the number of morbidity and mortality.

The study evaluates the difference in capillary perfusion density, AKI stage (based on KDIGO criteria), and the Cardiac index value between groups septic shock patients with CVP 0-4 mmHg on the 7th day after deresuscitation compared with the control group (CVP 8-10 mmHg on the first 7th day after being given deresuscitation).

The study evaluates the difference in the number of intubation incidents, duration of use ventilators, and care in the ICU between groups of patients with septic shock CVP 0 - 4 on day 28 after being given a degree of comparison with a control group (CVP 8-10 mmHg on day 28th after being deresuscitation).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: November 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Septic shock patients who meet the diagnosis criteria for quick SOFA and KDIGO 1 stage AKI (creatinine value 1.5 times OR creatinine value> 0.3 initial OR urine production <0.5 ml/kg/hour for 6-12 hours

• Patients, both men and women, in the age range of 18 - 60 years

• Patients who experience post clean operative sepsis

• Patients who agree to attend the study by signing informed consent

Exclusion Criteria:

• Patients with primary heart problems, right or heart failure suffer from congenital heart disease

• Have severe chronic obstructive pulmonary disease, patients with severe pleural effusion

• Patients who, based on ultrasound examination, found stones or tumors in the kidney during the study period

• CKD patients are based on history taking and physical examination

• DNR (do not resuscitate) patients

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Procedure:
• Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 - 10 mmHg
Crystalloid loading or furosemide administration with the CVP target 8-10 mmHg is reached in septic shock patients
• Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 - 4 mmHg
active fluid removal with furosemide bolus and continuous or crystalloid loading until the CVP target 0-4 mmHg is reached in septic shock patients

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (10)

Cordemans C, De Laet I, Van Regenmortel N, Schoonheydt K, Dits H, Huber W, Malbrain ML. Fluid management in critically ill patients: the role of extravascular lung water, abdominal hypertension, capillary leak, and fluid balance. Ann Intensive Care. 2012 — 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, Zimm — 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 — View Citation

Opal SM, Laterre PF, Francois B, LaRosa SP, Angus DC, Mira JP, Wittebole X, Dugernier T, Perrotin D, Tidswell M, Jauregui L, Krell K, Pachl J, Takahashi T, Peckelsen C, Cordasco E, Chang CS, Oeyen S, Aikawa N, Maruyama T, Schein R, Kalil AC, Van Nuffelen — View Citation

Payen D, de Pont AC, Sakr Y, Spies C, Reinhart K, Vincent JL; Sepsis Occurrence in Acutely Ill Patients (SOAP) Investigators. A positive fluid balance is associated with a worse outcome in patients with acute renal failure. Crit Care. 2008;12(3):R74. doi: — View Citation

Prowle JR, Echeverri JE, Ligabo EV, Ronco C, Bellomo R. Fluid balance and acute kidney injury. Nat Rev Nephrol. 2010 Feb;6(2):107-15. doi: 10.1038/nrneph.2009.213. Epub 2009 Dec 22. Review. — 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 — View Citation

Van Biesen W, Yegenaga I, Vanholder R, Verbeke F, Hoste E, Colardyn F, Lameire N. Relationship between fluid status and its management on acute renal failure (ARF) in intensive care unit (ICU) patients with sepsis: a prospective analysis. J Nephrol. 2005 — View Citation

Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb — View Citation

Wang CH, Hsieh WH, Chou HC, Huang YS, Shen JH, Yeo YH, Chang HE, Chen SC, Lee CC. Liberal versus restricted fluid resuscitation strategies in trauma patients: a systematic review and meta-analysis of randomized controlled trials and observational studies* — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capillary Perfusion Density	Capillary Perfusion Density measurement using MicroScan every 24 hours during deresuscitation	7 days
Secondary	Acute Kidney Injury Stage	AKI staging using KDIGO criteria every 24 hours during deresuscitation	7 days
Secondary	Cardiac Index	cardiac index measurement using bio-impedance cardiometry every 24 hours during deresuscitation	7 days
Secondary	Neutrophil Gelatinase-Associated lipocalin (NGAL)	NGAL measurement from urinary sample using NGAL ELISA method at 1st and 7th day during deresuscitation	1st and 7th day
Secondary	Renal Resistive Index (RRI)	RRI measurement using renal doppler ultrasonography at 1st and 7th day during deresuscitation	1st and 7th day
Secondary	Length of ICU stay	length of ICU stay in days during and after deresuscitation	28 days