Comparison of Colloid (20% Albumin) Versus Crystalloid (Plasmalyte) for Fluid Resuscitation in Cirrhotics With Sepsis Induced Hypotension.

Not Applicable

Completed

• Conditions: Cirrhosis With Sepsis
• Interventions: Other: Plasmalyte; Biological: 20% Albumin

• Registration Number: NCT02721238
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

Consecutive cirrhotics who present to emergency department of Institute of Liver \& Biliary Sciences with documented or suspected sepsis induced hypotension will be randomized to receive either human albumin infusion over 3 hours or plasmalyte as per requirement. At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. The aim of study is to compare the efficacy of using 20% human albumin versus plasmalyte in resuscitation of the patient that is attainment of mean arterial pressure above 65 mm of Hg at three hour after intervention and sustenance of mean arterial pressure above 65 mm of Hg at 6th hour. The randomized patient will be administered 20% albumin (0.5-1.0 gm/kg) for 3 hours, or plasmalyte at the rate of 30ml/kg. After the intervention changes in MAP (Mean Arterial Pressure), lactate level, urine output, incidence of complications, duration of ventilator, ICU (Intensive Care Unit) stay and mortality after one week will be studied.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-01
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-29
• Study Start: 2016-12-01
• Primary Completion: 2018-11-03
• Study Completion: 2018-11-03
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-21
• Last Update Posted: 2021-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients of cirrhosis with suspected or documented sepsis with MAP < 65 mm Hg

Exclusion Criteria

• Age <18 years or > 75 yrs
• Already received colloid or 2 litres of fluid within the first 12 hours of presentation
• Already on vasopressors and/or inotropes
• Patients with Spontaneous Bacterial Peritonitis and serum albumin less then 1.5g/dl
• Patient with structural heart disease
• On maintenance hemodialysis
• Other causes of hypotension
• Pregnant or lactating women
• Patients in need for emergent surgical interventions
• Known chronic obstructive lung disease and congestive heart failure
• A previous adverse reaction to human albumin solution

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resuscitation with 30ml/kg plasmalyte	Plasmalyte	-
Resuscitation with 20% Albumin	20% Albumin	-

Primary Outcome Measures

Name	Time	Method
Reversal of hypotension in both groups	3 hours	Reversal is defined as Mean Arterial Pressure (MAP) \> 65 mmHg after 3 hours of resuscitation

Secondary Outcome Measures

Name	Time	Method
Survival time during the first 28 days	28 days
Mortality in both groups	7 days
Proportion of patients with new organ failures.	28 days
Duration of mechanical ventilation.	28 days
Requirement of renal-replacement therapy.	28 days	Renal-replacement therapy. is defined as patients who required hemodialysis , SLED (Sustained Low efficiency Dialysis) or CRRT (Continous renal replacement therapy).
The duration of the Intensive Care Unit stay.	28 days

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India