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

NCT05095857 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-06-26

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Trine H Andreasen, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2028-09-15
Completion
2028-09-15

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT05095857 on ClinicalTrials.gov