A Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction (BALANCE Study)

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

February 29, 2016

Study Completion Date

April 30, 2016

Conditions
Sepsis
Interventions
OTHER

Conservative Fluid Management Strategy

For patients in the conservative fluid management arm, beginning 12 hours after admission to study ICU and ending at the first of ICU discharge, death, return to home inspired oxygen, or study day 14, fluid management will be controlled by a study protocol. Patients in shock will receive fluid boluses only as specified by the protocol for oliguria and rapidly increasing vasopressor requirement. Patients not in shock will receive fluid boluses only as specified by the protocol for oliguria. Output will exceed input each day using a diuretic drip if required. Study protocol will be held only for pre-specified Safety Endpoints of persistent oliguria, decompensating shock, diuretic side effect, and intervening acute event.

Trial Locations (1)

37232

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University

OTHER

NCT02159079 - A Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction (BALANCE Study) | Biotech Hunter | Biotech Hunter