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ClinicalTrials.gov ID

NCT07319208

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

760Estimated

Last Update Posted

Jul 29, 2026Actual

Start Date

Apr 21, 2026Actual

Primary Completion Date

Jun 1, 2028Estimated

Completion Date

Jun 1, 2029Estimated

Official Title

Efficacy of Early Continuous Infusion of Hypertonic Saline Solution on the Neurological Outcome at 6 Months in Traumatic Brain Injured Patients. A Single-blinded, Multicenter, Randomized, Controlled Clinical Trial With Blinded Evaluation of the Primary Outcome.

Brief Summary

The purpose of this study is to demonstrate the efficacy of early continuous intravenous infusion of hypertonic saline solution (HSS) to improve survival and independence in daily life activities (at 6 months) of patients with traumatic brain injury at high risk of intracranial hypertension.

• TBI Traumatic Brain Injury

• Hypertonic saline solution

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Patient admitted to intensive care unit
• Traumatic brain injury with Glasgow Coma Scale ≤ 12
• Intracranial pressure (ICP) monitoring based on the attending physician's clinical judgment, in accordance with guidelines or clinical/radiological signs considered at risk of intracranial hypertension
• Inclusion during the first 12 hours after Intracranial pressure monitoring placement
• Informed and signed consent
• National health insurance

Exclusion Criteria:

• Glasgow Coma Scale (score = 3) and persistent abnormal pupillaryreactivity despite urgent therapy
• Associated cervical spinal cord injury
• Imminent death and do-not-resuscitate orders
• Coma secondary to cardiac arrest
• Pregnancy (serum or urine test performed in routine care)
• Severe Cardiac insufficiency
• Severe chronic renal insufficiency
• Severe hepatic insufficiency: patient presenting with oedemato-ascitic decompensation of liver cirrhosis or patient with Child-Pugh class C cirrhosis
• High risk of follow-up difficulties after ICU discharge
• Patients under court protection
• Patient who does not speak French

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

Nantes University HospitalOTHER

marwan.bouras@chu-brest.fr

natalie.desa@chu-lille.fr

baptiste.balanca@chu-lyon.fr

marc.leone@ap-hm.fr

yannick.hourmant@chu-nantes.fr+33240087380

maiziere.em@chu-nice.fr

yoann.launey@chu-rennes.fr