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

Primary Purpose

Cirrhosis With Sepsis

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

20% Albumin

Plasmalyte

About this trial

This is an interventional treatment trial for Cirrhosis With Sepsis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Institute of Liver & Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Resuscitation with 30ml/kg plasmalyte

Resuscitation with 20% Albumin

Arm Description

Outcomes

Primary Outcome Measures

Reversal of hypotension in both groups

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

Secondary Outcome Measures

Mortality in both groups

Survival time during the first 28 days

Proportion of patients with new organ failures.

Duration of mechanical ventilation.

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).

The duration of the Intensive Care Unit stay.

Full Information

NCT ID

NCT02721238

First Posted

March 1, 2016

Last Updated

August 21, 2021

Sponsor

Institute of Liver and Biliary Sciences, India

1. Study Identification

Unique Protocol Identification Number

NCT02721238

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

December 1, 2016 (Actual)

Primary Completion Date

November 3, 2018 (Actual)

Study Completion Date

November 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cirrhosis With Sepsis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Resuscitation with 30ml/kg plasmalyte

Arm Type

Active Comparator

Arm Title

Resuscitation with 20% Albumin

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

20% Albumin

Intervention Type

Other

Intervention Name(s)

Plasmalyte

Primary Outcome Measure Information:

Title

Reversal of hypotension in both groups

Description

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

Time Frame

3 hours

Secondary Outcome Measure Information:

Title

Mortality in both groups

Time Frame

7 days

Title

Survival time during the first 28 days

Time Frame

28 days

Title

Proportion of patients with new organ failures.

Time Frame

28 days

Title

Duration of mechanical ventilation.

Time Frame

28 days

Title

Requirement of renal-replacement therapy.

Description

Renal-replacement therapy. is defined as patients who required hemodialysis , SLED (Sustained Low efficiency Dialysis) or CRRT (Continous renal replacement therapy).

Time Frame

28 days

Title

The duration of the Intensive Care Unit stay.

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Abhinav Verma, MD

Organizational Affiliation

Institute of Liver and Biliary Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institute of Liver & Biliary Sciences

City

New Delhi

State/Province

Delhi

ZIP/Postal Code

110070

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

35460725

Citation

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.

Results Reference

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

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