Trials Sponsors Conditions Drugs Pricing

Conditions

Fluid Overload Outcome, Fatal Traumatic Brain Injury

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 balanceProcedure

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

Neutral balance

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age16 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (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

Sponsors & Collaborators

Universita degli Studi di Genova
Otherlead

MeSH Terms

Conditions

Brain Injuries, TraumaticEdema

Interventions

Water-Electrolyte Balance

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Standard of care group

Neutral balance

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (2)

Standard of care group

Neutral balance

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record