Clinical trial NCT02721238: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis With Sepsis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reversal of hypotension in both groups
timeFrame: 3 hours
Secondary outcomes:
measure: Mortality in both groups
timeFrame: 7 days
measure: Survival time during the first 28 days
timeFrame: 28 days
measure: Proportion of patients with new organ failures.
timeFrame: 28 days
measure: Duration of mechanical ventilation.
timeFrame: 28 days
measure: Requirement of renal-replacement therapy.
timeFrame: 28 days
measure: The duration of the Intensive Care Unit stay.
timeFrame: 28 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Abhinav Verma, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.