drugset / Trial / NCT02462902

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

NCT02462902

RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2014-02
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Albumin Protein / enzyme biologic 5 %
Subject Albumin Protein / enzyme biologic 250 ml
Comparator sodium chloride Unknown 0.9 %
Comparator sodium chloride Unknown 30 unknown

Indications