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RECRUITING
NCT05095857
PHASE4

The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury

Sponsor: Rigshospitalet, Denmark

View on ClinicalTrials.gov

Summary

Cortical spreading depolarisations are pathological depolarisation waves that occur frequently after severe acute brain injury and has been associated with poor outcome. S-ketamine has been shown to inhibit cortical spreading depolarisations. The aim of the present study is to examine the efficacy and safety of using S-ketamine for treatment of patients with severe acute brain injury, as well as the feasibility of the trial design.

Official title: S-ketamine for Cortical Spreading Depolarisation in Patients With Severe Acute Brain Injury

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2023-09-15

Completion Date

2028-09-15

Last Updated

2024-06-26

Healthy Volunteers

No

Interventions

DRUG

S-ketamine

S-ketamines is an NMDA-receptor antagonist with sedative and analgesic properties. It will in the present trial be given in sedative doses (2-3 mg/kg/hour) in case of clustered SDs following a dosing algorithm according to SD occurrence.

OTHER

Isotonic saline (placebo)

Isotonic saline has the same appearance as S-ketamine with both being clear liquids with no bubbles or other distinguishing features.

Locations (1)

Rigshospitalet

Copenhagen, Denmark