MedTrace Logo

Ketamine in Acute Brain Injury Patients.

NCT05097261 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-22

No results posted yet for this study

Summary

Although, in the past years, an increasing use of ketamine in Traumatic Brain injury (TBI) has been reported as an adjunct to other sedatives, there is no evidence from randomized clinical trial to support this practice.

The BIKe (Brain Injury and Ketamine) study is a double-blind placebo controlled randomized multicenter clinical trial to examine the safety and feasibility of using ketamine as an adjunct to a standard sedative strategy in TBI patients.

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).

Sponsors & Collaborators

  • University of Liege

    collaborator OTHER

  • Centre Hospitalier Régional de la Citadelle

    collaborator OTHER

  • AZ Delta

    collaborator OTHER

  • AZ Sint-Jan AV

    collaborator OTHER

  • AZ Turnhout

    collaborator OTHER

  • Imelda Hospital, Bonheiden

    collaborator OTHER

  • Geert Meyfroidt, MD, PhD

    lead OTHER

Principal Investigators

  • Geert Meyfroidt, MD PhD · Associate Professor of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-06
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05097261 on ClinicalTrials.gov