Completed

NCT Number: NCT02721238

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cirrhosis With Sepsis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

20% Albumin

Biological

plasmalyte

Other

Primary outcomes

Reversal of hypotension in both groups

Time frame: 3 hours

Reversal is defined as Mean Arterial Pressure (MAP) > 65 mmHg after 3 hours of resuscitation

Secondary outcomes

Mortality in both groups

Time frame: 7 days
Survival time during the first 28 days

Time frame: 28 days
Proportion of patients with new organ failures.

Time frame: 28 days
Duration of mechanical ventilation.

Time frame: 28 days
Requirement of renal-replacement therapy.

Time frame: 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.

Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Mar 29, 2016
Registry last updated: Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.