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

NCT05983549 | Unknown DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Traumatic Brain Injury; Fluid Overload; Outcome, Fatal

Outcome Measures

Primary Outcomes (1)

• Feasibility- rate of patients able to achieve neutral fluid balance( 0 +/- 500 ml) during the first week from ICU admission

  Ability to target and achieve a daily and total neutral fluid balance (0 +/- 500 ml) in the intervention group. In particular,testing the hypothesis of whether all pairwise differences between group means are the same in a design of repeated measures with 7 days points. We hypothesise a mean of 0 ml in the conservative group, a mean of 1000 ml in the liberal group and standard deviation in the population of 850 ml (500 ml in the conservative group and 1000 ml in the liberal group)

  7 days

Secondary Outcomes (2)

• Safety to achieve neutral balance, i.e. the estimation of the difference of incidence of renal, pulmonary, cardiac complications between the two arms

  From date of randomization until the date of intensive care unit discharge or death assessed up to 6 months

• Rates of patients who die and experience poor neurological outcome after 6 months from ICU admission

  6 months from ICU admission and enrolment

Study Arms (2)

Standard of care group

NO INTERVENTION

Patients will receive fluids according to clinical practice

Neutral balance

ACTIVE COMPARATOR

Patients will receive fluids aiming to a neutral balance

Procedure: fluid balance

Interventions

fluid balance PROCEDURE

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

Neutral balance

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Enrolled in another clinical trial that is unapproved for co-enrolment
• Pregnant or suspected pregnancy
• 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)

Sponsors & Collaborators

• Universita degli Studi di Genova: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic; Edema

Interventions

Water-Electrolyte Balance

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Osmoregulation; Biochemical Phenomena; Chemical Phenomena; Metabolism; Homeostasis; Physiological Phenomena

Central Study Contacts

Chiara Robba, PhD

CONTACT

3473912338; kiarobba@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant will be blinded in knowing the arm, outcome assessors will be not involved in the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 9, 2023
• Study Start: September 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL