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

Cirrhosis With Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02721238
• Other study ID #: ILBS-Cirrhosis-03
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: November 3, 2018

Study information

• Verified date: August 2021
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 3, 2018
• Est. primary completion date: November 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis With Sepsis
• Hypotension
• Sepsis
• Toxemia

Intervention

Biological:
• 20% Albumin

Other:
• Plasmalyte

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reversal of hypotension in both groups	Reversal is defined as Mean Arterial Pressure (MAP) > 65 mmHg after 3 hours of resuscitation	3 hours
Secondary	Mortality in both groups		7 days
Secondary	Survival time during the first 28 days		28 days
Secondary	Proportion of patients with new organ failures.		28 days
Secondary	Duration of mechanical ventilation.		28 days
Secondary	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
Secondary	The duration of the Intensive Care Unit stay.		28 days