drugset / Trial / NCT06076330

Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension

NCT06076330

RandomizedParallel-groupOpen-labelTreatment

Summary

Cirrhotic patients with sepsis represent a very sick subset of patients and septic shock in such patients is associated with high mortality. Early initiation of intravenous fluids and antibiotics is the key to management in these patients. The choice of fluid in cirrhotic patients with sepsis induced hypotension has been studied in the past. The choice of fluid, crystalloid vs colloid, for resuscitation in such patients has been a matter of debate. In the previous study, the ALPS trial, 20% albumin use was associated with a better reversal of hypotension but was associated with an increased incidence of pulmonary complications and 5% albumin was better when compared to normal saline(FRISC study) for fluid resuscitation. No study in the past has evaluated 5% albumin against 20% albumin in combination with crystalloid. Investigator aim to study the efficacy and safety of 20% albumin with plasmalyte against 5 % albumin for fluid resuscitation in cirrhotic patients with sepsis induced hypotension.

Timeline

Start
2023-09-30
Primary completion
2024-08-31
Completion
2024-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Albumin Protein / enzyme biologic 5 % Intravenous
Subject Albumin Protein / enzyme biologic 20 % Intravenous
Subject Plasmalyte Other / unclassified 100 ml

Indications