NCT02721238

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2018

Completed
Last Updated

August 26, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

March 1, 2016

Last Update Submit

August 21, 2021

Conditions

Cirrhosis With Sepsis

Outcome Measures

Primary Outcomes (1)

  • Reversal of hypotension in both groups

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

    3 hours

Secondary Outcomes (6)

  • 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.

    28 days

  • +1 more secondary outcomes

Study Arms (2)

Resuscitation with 30ml/kg plasmalyte

ACTIVE COMPARATOR
Other: Plasmalyte

Resuscitation with 20% Albumin

EXPERIMENTAL
Biological: 20% Albumin

Interventions

20% AlbuminBIOLOGICAL
Resuscitation with 20% Albumin
PlasmalyteOTHER
Resuscitation with 30ml/kg plasmalyte

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of cirrhosis with suspected or documented sepsis with MAP \< 65 mm Hg

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

  • 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.

    PMID: 35460725DERIVED

MeSH Terms

Interventions

AlbuminsPlasmalyte A

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Dr Abhinav Verma, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 29, 2016

Study Start

December 1, 2016

Primary Completion

November 3, 2018

Study Completion

November 3, 2018

Last Updated

August 26, 2021

Record last verified: 2021-08

Locations

IN(1)