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

Study Overview
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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.

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

Conditions
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Cirrhosis With Sepsis

Intervention / Treatment
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* Biological: 20% Albumin
* Other: Plasmalyte


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resuscitation with 30ml/kg plasmalyte<br> | Other: Plasmalyte<br> <br> |
| Experimental: Resuscitation with 20% Albumin<br> | Biological: 20% Albumin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reversal of hypotension in both groups | Reversal is defined as Mean Arterial Pressure (MAP) > 65 mmHg after 3 hours of resuscitation | 3 hours | 

Secondary Outcome Measures

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