NCT05983549

Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial

The Effect of Neutral Versus Liberal fLuId Balance In TraumaTic Brain Injury: a Randomised Phase II Feasibility Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Universita degli Studi di Genova · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Feasibility and safety of targeting neutral vs liberal fluid balance in traumatic brain injured patients: a phase II randomized controlled trial

Detailed description

To determine whether a zero fluid balance strategy during the first week compared to a more liberal fluid policy (allowing positive balance) is feasible in adult intensive care unit (ICU) patients with traumatic brain injury (TBI).Participants randomized to neutral fluid balance will be assessed daily with the aim to maintain a mean daily fluid balance of 0 over the course of the first 5 days from randomization (maximum at day 7 of ICU stay). In case of need for augmentation of cerebral perfusion pressure with 0 balance, fluids will be allowed according to a predefined protocol (see further).Participants randomized to the control group will receive the standard fluid management required as determined by the treating team. Fluid strategy as randomised should be applied for at least 5 days from randomization. Primary aim: ● Feasibility: ability to achieve a daily neutral balance (0 +/- 500 ml) in the intervention group. Secondary aims:● Incidence of renal complications, including acute kidney injury, need for renal replacement, multiorgan failure * Respiratory complications including reduced partial pressure of oxygen/ fraction of inspired oxygen (P/F) ratio * Cardiopulmonary complications, i.e myocardial infarction, cardiac failure, cardiac arrhythmias, ventricular or supraventricular, pulmonary oedema, ventilator associated pneumonia, acute respiratory distress syndrome * Difference in mean and daily CPP among the groups * Difference in daily fluid balance and fluid input during the first 7 days after ICU admission * Total and daily dose of vasopressors and diuretics during ICU stay * Vasopressor-free days up to 28 days from ICU admission * ICU-free days up to 28 days * Ventilator-free days up to 28 days from intubation. * Maximum Therapy intensity level (TIL) during the 5 days of randomization

Conditions

• Traumatic Brain Injury
• Fluid Overload
• Outcome, Fatal

Interventions

Type	Name	Description
PROCEDURE	fluid balance	patients will receive fluids with the aim to achieve a neutral balance

Timeline

• Start date: 2023-09-01
• Primary completion: 2025-05-01
• Completion: 2025-09-01
• First posted: 2023-08-09
• Last updated: 2023-08-09