Hypertonic saline solution
DrugContinuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
NCT Number: NCT07319208
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Phase 3
CHU d'Angers, Angers, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous infusion of HSS (NaCl 20%) for 48 hours (can be prolonged during the period of intracranial hypertension)
Time frame: 3 months
Survival : number of patients still alive
Time frame: 6 months
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: 7 days
Evolution of blood sodium level
Time frame: 7 days
Evolution of blood chloride level
Time frame: 7 days
Evolution of solute concentration in blood plasma
Time frame: 7 days
Number of therapeutic interventions with the TIL (Therapeutic Intensity Level) scale.
Time frame: until 12 months
Survival : number of patients still alive
Time frame: until 12 month
Score of EQ-5D-5L (5-level EuroQol-5D version) : minimum - maximal values: 1-5, higher scores mean a worse outcome.
Time frame: until 12 months
Rates of patient living at home, at rehabilitation centers or at hospital
Time frame: until 6 months
Galveston Orientation and Amnesia Test (G.O.A.T) : minimum - maximal values: 0-100, higher scores mean a better outcome.
Time frame: 6 months
Montreal Cognitive Assessment (MOCA) : minimum - maximal values: 0-30, higher scores mean a better outcome.
Time frame: 6 months
Glasgow Outcome Scale Extended (GOS-E) : minimum - maximal values: 1-8, higher scores mean a better outcome.
Time frame: 1 month
Rates severe hypernatremia (Na> 160 mmol/L)
Time frame: 1 month
Rates of acute kidney injury
Time frame: 1 month
Number of thrombotic events
Time frame: 1 month
Number of entral-pontine myelinolysis
Time frame: 12 months
Incremental cost-effectiveness ratio
Time frame: 12 months
Single nucleotide polymorphism
Contact information is provided by the study sponsor or research team.
Antoine ROQUILLY
CONTACT
Astrid GARREAU
CONTACT
Nantes University Hospital
Other
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.
Acronym: COSMOS-TBI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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