Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNantes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypertonic saline solution

    Drug

    Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)

Treatment groups

760 Participants
are divided into 2 treatment groups
Group A: Hypertonic Saline SolutionExperimental treatment 1 intervention
Group B: StandardNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Efficacy of early continuous of HSS

Survival : number of patients still alive

Time frame
3 months
2

Efficacy of early continuous of HSS

Rate of moderate to no dependency in activities in daily living at 6 months is defined as a Barthel Index of independence in activities in daily living ≥ 61.

Time frame
6 months

Secondary outcomes

1

Treatment of intracranial hypertension

Evolution of blood sodium level

Time frame
7 days
2

Treatment of intracranial hypertension

Evolution of blood chloride level

Time frame
7 days
3

Treatment of intracranial hypertension

Evolution of solute concentration in blood plasma

Time frame
7 days
4

Neurological recovery

Number of therapeutic interventions with the TIL (Therapeutic Intensity Level) scale.

Time frame
7 days

Other outcomes

Sponsors and contacts

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