Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05983549
Study type	Interventional
Source	Universita degli Studi di Genova
Contact	Chiara Robba, PhD
Phone	3473912338
Email	kiarobba@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	September 1, 2023
Completion date	September 1, 2025

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms