NCT01337934

Lactated Ringer Versus Albumin in Early Sepsis Therapy

Ringer Versus Albumin In Septic Patients: a Randomized Controlled Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Septic Shock
• Severe Sepsis

Interventions

Type	Name	Description
DRUG	Lactated Ringer	Lactated Ringer
DRUG	Albumin	Albumin 4%

Timeline

• Start date: 2013-10-01
• Primary completion: 2016-10-01
• Completion: 2017-12-01
• First posted: 2011-04-19
• Last updated: 2018-04-05

Locations

1 site across 1 country: Brazil