drugset / Trial / NCT01337934

Lactated Ringer Versus Albumin in Early Sepsis Therapy

NCT01337934

Phase 3 Completed 360 enrolled University of Sao Paulo
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The use of albumin in critical ill patients is a matter of controversy. A large randomized controlled trial reported that albumin was as safe and effective as crystalloid solution for fluid replacement in intensive care unit, although the last one was less expensive. In Surviving Sepsis Campaign International Guidelines there are no preference for crystalloids over colloids. But recently, a retrospective analysis of patients with severe sepsis from SAFE study reported that the use of albumin in these patients would be superior, regarding reduction of mortality. The aim of this study is determine whether the use of albumin improve clinical outcomes in patients with severe sepsis or septic shock.

Timeline

Start
2013-10
Primary completion
2016-10
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Albumin Protein / enzyme biologic 500 ml
Comparator Lactated Ringer Other / unclassified 500 ml