Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

October 31, 2017

Primary Completion Date

March 5, 2020

Study Completion Date

March 5, 2020

Conditions
Moderate to Severe Traumatic Brain Injury
Interventions
DRUG

NaCl20% (Continuous hyperosmolar therapy)

"Early intravenous administration (\<24 hours after traumatic brain injury) of NaCl20% for a minimal duration of 48 hours (continued for as long as is necessary to prevent intracranial hypertension)~1-hour bolus (15 g if Na+ \< 145 mmol/L; 7.5 g if 145 \< Na+ \< 150 mmol/L; or no bolus) followed by 1 g/hour as long as Na+\< 150 mmol/L, reduced to 0.5 g/L if 150 \< Na+ \< 155 mmol/L, Discontinuation when 155 mmol/L\<Na+"

Trial Locations (10)

29600

CHU Brest Hopital La Cavale Blanche, Brest

31059

CHU Toulouse Hôpital Pierre-Paul Riquet, Toulouse

37044

CHU Tours, Tours

44093

CHU de Nantes, Nantes

75014

Centre Hospitalier Sainte-Anne, Paris

86000

CHU Poitiers, Poitiers

92118

AP-HP Beaujon, Clichy

Unknown

CHU Angers, Angers

CHU Montpellier, Montpellier

CHU Rennes-Hopital Pontchaillou, Rennes

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT03143751 - Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients | Biotech Hunter | Biotech Hunter