Ketamine in Acute Brain Injury Patients.

PHASE4RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 6, 2021

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Brain Injuries, Traumatic
Interventions
DRUG

Ketamine

Racemic ketamine® will be administered by continuous infusion in a prefilled 50 ml syringe at a concentration of 50 mg/ml, undiluted. The ketamine dose is 1 mg/kg/h, to a maximum dose of 120 mg/hour, which corresponds to an infusion rate of 0.02 ml/kg/h to a maximum rate of 2.4 ml/h.

DRUG

Placebo

Placebo (NaCl 0.9%) will be provided in the same type syringes and administered at the same infusion rate as the IMP (0.02 ml/kg/h to a maximum rate of 2.4 ml/h).

Trial Locations (8)

3001

RECRUITING

UZLeuven, Leuven

3500

RECRUITING

Jessa Ziekenhuis, Hasselt

Unknown

RECRUITING

Imelda Bonheiden, Bonheiden

RECRUITING

AZ Sint-Jan, Bruges

RECRUITING

CHR de la Citadelle Liège, Liège

RECRUITING

CHU de Liège, Liège

RECRUITING

AZ Delta, Roeselare

RECRUITING

AZ Turnhout, Turnhout

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University of Liege

OTHER

collaborator

Centre Hospitalier Régional de la Citadelle

OTHER

collaborator

AZ Delta

OTHER

collaborator

AZ Sint-Jan AV

OTHER

collaborator

AZ Turnhout

OTHER

collaborator

Imelda Hospital, Bonheiden

OTHER

lead

Geert Meyfroidt, MD, PhD

OTHER

NCT05097261 - Ketamine in Acute Brain Injury Patients. | Biotech Hunter | Biotech Hunter