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.

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-520205-39-00

Acronym

RC24_0543

Enrollment

760

Registered

2025-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic brain injury

Brief summary

The co-primary hierarchic endpoints will be survival at 3 months and moderate to no dependency in activities in daily living at 6 months, which will be assessed centrally by a blinded evaluator.

Detailed description

Evolution of natremia, chloremia, and plasma osmolarity (7 days), Therapeutic intensity level during the first 7 days, Survival at 1, 6 and 12 months, EQ-5D-5L at 1, 3, 6 and 12 months (quality-adjusted life year), Residency at 1, 3, 6 and 12 months, G.O.A.T at 1, 3 and 6 months, MOCA, GOS-E at 6 months, Rates severe hypernatremia (Na> 160 mmol/L) at Month 1, Rates of acute kidney injury at Month 1 (KDIGO score 2-3), Safety (thrombotic events, central-pontine myelinolysis), Incremental cost-effectiveness ratio with a one-year time horizon, Single nucleotide polymorphism correlated with the clinical outcome

Interventions

DRUGSODIUM CHLORIDE

DRUGMANNITOL

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The co-primary hierarchic endpoints will be survival at 3 months and moderate to no dependency in activities in daily living at 6 months, which will be assessed centrally by a blinded evaluator.	—

Secondary

Measure	Time frame
Evolution of natremia, chloremia, and plasma osmolarity (7 days), Therapeutic intensity level during the first 7 days, Survival at 1, 6 and 12 months, EQ-5D-5L at 1, 3, 6 and 12 months (quality-adjusted life year), Residency at 1, 3, 6 and 12 months, G.O.A.T at 1, 3 and 6 months, MOCA, GOS-E at 6 months, Rates severe hypernatremia (Na> 160 mmol/L) at Month 1, Rates of acute kidney injury at Month 1 (KDIGO score 2-3), Safety (thrombotic events, central-pontine myelinolysis), Incremental cost-effectiveness ratio with a one-year time horizon, Single nucleotide polymorphism correlated with the clinical outcome	—

Measure

Time frame

—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026