Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients: a Phase II Randomized Controlled Trial - LIMIT-TBI Trial

What this Trial Is About

Researchers are evaluating the safety and feasibility of maintaining a near-neutral daily fluid balance compared to standard fluid management in critically ill adults with traumatic brain injury (TBI). This international, multicenter, randomized phase II trial addresses uncertainty about optimal fluid therapy strategies to prevent complications like brain swelling or low blood volume, which can affect recovery and survival. The study aims to provide important preliminary evidence to guide future treatments for this serious condition. Participants admitted to intensive care units with TBI are randomly assigned within 48 hours to one of two groups. One group follows a protocol targeting a daily fluid balance close to zero (±500 mL) using restricted fluids, diuretics, and vasopressors over the first 5 days. The other group receives standard fluid management based on local clinical practices without a specific fluid balance goal. Both groups have their fluid inputs and outputs closely monitored while maintaining blood pressure and cerebral perfusion targets. During the study, participants will undergo close monitoring of fluid balance, organ function, blood pressure, and neurological status. Researchers will track outcomes including the feasibility of achieving neutral fluid balance, organ complications, use of medications like vasopressors and diuretics, days without organ support, mortality, and neurological recovery up to six months after randomization. The study involves detailed assessments during ICU stay and follow-up evaluations to understand the impact of fluid strategies on recovery and survival.

Feasibility and Safety of Targeting Neutral vs Liberal Fluid Balance in Traumatic Brain Injured Patients- LIMIT-TBI Trial