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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-11-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis With Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Resuscitation with 30ml/kg plasmalyte

Group Type ACTIVE_COMPARATOR

Plasmalyte

Intervention Type OTHER

Resuscitation with 20% Albumin

Group Type EXPERIMENTAL

20% Albumin

Intervention Type BIOLOGICAL

Interventions

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20% Albumin

Intervention Type BIOLOGICAL

Plasmalyte

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No