Actively Recruiting
Led by Geert Meyfroidt, MD, PhD · Updated on 2024-08-22
100
Participants Needed
8
Research Sites
25 weeks
Total Duration
G
Geert Meyfroidt, MD, PhD
Lead Sponsor
U
University of Liege
Collaborating Sponsor
Researchers are evaluating the effects of ketamine as an additional sedative in adults with traumatic brain injury (TBI) admitted to intensive care units. This Phase 4, double-blind, randomized, placebo-controlled trial aims to study the safety and feasibility of ketamine combined with standard sedation methods, focusing on its impact on intracranial pressure and the intensity of therapy required to manage it. Participants will receive standard sedation with propofol up to a maximum dose, with midazolam added if needed. Pain relief is provided by remifentanil, fentanyl, or sufentanil infusions. Study medication, either ketamine or placebo, is started within six hours after randomization and administered continuously by infusion. Decisions regarding additional treatments like decompressive craniectomy or barbiturate coma are made by the medical team as per usual care, and the study drug is stopped if barbiturate coma is used. Participants will be closely monitored through various measures including intracranial pressure, sedation duration, medication doses, mechanical ventilation, length of ICU and hospital stay, agitation-sedation scales, delirium presence, and mortality up to six months after treatment starts. Safety and therapy intensity levels are assessed during treatment and follow-up. The study duration extends until hospital discharge or death, with outcomes measured up to six months.
CONDITIONS
Ketamine in Acute Brain Injury Patients.
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Duration - Up to 72 hours after hospital admission
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From randomization until study drug discontinuation or death, up to 6 months
Participants receive continuous infusion of ketamine or placebo alongside standard sedation and pain relief medications to manage intracranial pressure after traumatic brain injury.
Continuous infusion during ICU stay with daily monitoring visits
Duration - Up to 6 months after treatment ends
Participants are monitored for clinical outcomes including sedation duration, intracranial pressure control, length of ICU and hospital stay, and survival up to 6 months after treatment.
Periodic follow-up visits up to 6 months post-treatment
Total: 8 locations
1
Imelda Bonheiden
Bonheiden, Belgium
Actively Recruiting
2
AZ Sint-Jan
Bruges, Belgium
Actively Recruiting
3
Jessa Ziekenhuis
Hasselt, Belgium, 3500
Actively Recruiting
4
UZLeuven
Leuven, Belgium, 3001
Actively Recruiting
5
CHR de la Citadelle Liège
Liège, Belgium
Actively Recruiting
6
CHU de Liège
Liège, Belgium
Actively Recruiting
7
AZ Delta
Roeselare, Belgium
Actively Recruiting
8
AZ Turnhout
Turnhout, Belgium
Actively Recruiting
L
Liese Mebis, PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Veerle De Sloovere, Liese Mebis, Pieter Wouters...
https://pubmed.ncbi.nlm.nih.gov/40437634