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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis With Sepsis
• Intervention / Treatment: Other: Plasmalyte; Biological: 20% Albumin

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Abhinav Verma, MD, Institute of Liver and Biliary Sciences

Publications and helpful links

General Publications

• Maiwall R, Kumar A, Pasupuleti SSR, Hidam AK, Tevethia H, Kumar G, Sahney A, Mitra LG, Sarin SK. A randomized-controlled trial comparing 20% albumin to plasmalyte in patients with cirrhosis and sepsis-induced hypotension [ALPS trial]. J Hepatol. 2022 Sep;77(3):670-682. doi: 10.1016/j.jhep.2022.03.043. Epub 2022 Apr 20.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): November 3, 2018
• Study Completion (Actual): November 3, 2018

Study Registration Dates

• First Submitted: March 1, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 21, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Hypotension; Pharmaceutical Solutions; Ophthalmic Solutions; Plasma-lyte 148
• Other Study ID Numbers: ILBS-Cirrhosis-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided