The Anaesthetic Ketamine as Treatment for Patients With Severe Acute Brain Injury
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Admitted to the NICU with a diagnosis of traumatic brain injury (TBI), aneurysmal subarachnoid haemorrhage (aSAH) or spontaneous intracerebral haemorrhage (ICH).
Planned for surgery with a supratentorial craniotomy or craniectomy.
Expected to continue sedation and mechanical ventilation after surgery.
Disqualifiers
Neither patient or next of kin understand Danish or English.
Known allergy to S-ketamine (the active pharmaceutical ingredient or the excipients).
Wake-up call to occur immediately after surgery.
Pregnancy (all female participants aged ≤ 50 years will have a urine or blood hCG taken to control for pregnancy).
Trial design
Design model
Parallel
Treatments tested in this trial
S-ketamine
DrugS-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.
Isotonic saline (placebo)
Other interventionIsotonic saline has the same appearance as S-ketamine with both being clear liquids with no bubbles or other distinguishing features.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: S-ketamineActive comparator 1 intervention
Group B: Isotonic salinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of SDs after randomisation
Efficacy of S-ketamine on the occurrence of cortical spreading depolarisations
Time frame
From randomisation to end of ECoG monitoring, expected to be a maximum of 14 daysSecondary outcomes
1
Rate of adverse events and adverse reactions
Time frame
During treatment with S-ketamine or placebo, a maximum of 14 days2
Functional outcome at 6 months after randomisation
assessed using modified Rankin Scale
Time frame
6 months after randomisationOther outcomes
1
All-cause mortality
Time frame
assessed at 6 months after randomisation2
Number of participants with signs of ischaemia or infarction on computed tomography (CT) or magnetic resonance imaging (MRI).
Last scan performed on clinical indication before discharge from NICU or semi-intensive care unit
Time frame
Before discharge from NICU or the semi-intentisive care unit, expected up to be no later than day 21 postrandomisation3
Occurrence of metabolic crisis (defined as microdialysis (MD)-lactate/pyruvate ratio >40, MD-glucose < 0.8 μmol/L)
Time frame
Postrandomisation period, expected up to 21 days4
Occurrence of local cerebral hypoxia (PbtO2 <20 mmHg for more than 20 minutes)
Time frame
Postrandomisation period, expected up to 21 daysSponsors and contacts
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Rigshospitalet, Denmark
Lead sponsor
Copenhagen Trial Unit, Center for Clinical Intervention Research
Collaborator
Source ClinicalTrials.gov