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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Cirrhosis With Sepsis

Treatments: Other: Plasmalyte; Biological: 20% Albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT02721238

ILBS-Cirrhosis-03

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Resuscitation with 30ml/kg plasmalyte

Active Comparator group

Treatment:

Other: Plasmalyte

Resuscitation with 20% Albumin

Experimental group

Treatment:

Biological: 20% Albumin