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

NCT ID: NCT05983549

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-09-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard of care group

Patients will receive fluids according to clinical practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Neutral balance

Patients will receive fluids aiming to a neutral balance

Group Type: ACTIVE_COMPARATOR

fluid balance

Intervention Type: PROCEDURE

patients will receive fluids with the aim to achieve a neutral balance

Interventions

fluid balance

patients will receive fluids with the aim to achieve a neutral balance

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Adult patients with TBI (isolated or with extracranial injuries, with and without ICP monitoring)
• Admitted to intensive care unit
• Age >18 years
• Enrolment <48h after ICU admission

Exclusion Criteria

• Enrolled in another clinical trial that is unapproved for co-enrolment
• Pregnant or suspected pregnancy
• Concomitant hemorrhagic shock expected to require surgical treatment in the following 24h from inclusion or requiring polytransfusions (> 6 blood products or massive transfusion protocol)
• Hemodynamic instability (HR > 120 despite fluid resuscitation of at least 1 liter, and systolic blood pressure < 90 mmHg) at the ICU admission requiring high dosage of norepinephrine (> 0.5 mcg/kg/min) or inotropes (any dose)

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita degli Studi di Genova

OTHER

Sponsor Role: lead

Responsible Party

Chiara Robba

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Chiara Robba, PhD

Role: CONTACT

kiarobba@gmail.com

3473912338

Other Identifiers

001

Identifier Type: -

Identifier Source: org_study_id