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Comparison And Outcomes Of Fluid Resucitation With 0.9% Normal Saline And 5% Albumin In Cirrhosis Patients With Sepsis Induced Hypotension

NCT02462902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2015-12-30

No results posted yet for this study

Summary

300 consecutive patients with cirrhosis of any aetiology admitted with features of sepsis and sepsis induced hypotension to the intensive care unit, the emergency department and the step down units of Institute of Liver and Biliary Sciences, New Delhi, who fulfil the inclusion criteria.

This study will be a single centre prospective randomized comparative trial. Patients will be randomized into two groups. Group A will receive crystalloid, 0.9% sodium chloride solution (total of 30ml/kg over 30 minutes) and Group B will receive colloid, 5% albumin (250 ml over 15 minutes).

Conditions

  • Cirrhosis With Septic Shock

Interventions

DRUG

5% albumin Infusion

colloid, 5% albumin (250 ml over 15 to 30 minutes).

DRUG

0.9% sodium chloride solution

0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes)

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02462902 on ClinicalTrials.gov