- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03226197
Feasibility and Safety of Delivering a Ketone Drink to Comatose Survivors of Out-of-hospital Cardiac Arrest
Every year, efforts are made to resuscitate about 30,000 people when their hearts stop outside of the hospital environment ('out-of-hospital cardiac arrest'). Early damage to the brain due to 'oxygen starvation' (seemingly paradoxically) gets worse when blood flow is restored. Of the 6,350 survivors admitted to intensive care units, 46% die from brain damage, and half of those who survive suffer long-term brain damage. Apart from avoiding a high temperature, nothing has been found which can protect the brain or improve outcome.
'Ketones' are chemicals naturally produced in the body from fat during starvation. They act as an energy source, but also as regulators of metabolism, and appear to protect cells from damage when oxygen supplies are scarce, or when blood flow is restored. The investigators want to see whether a ketone drink will protect the brain after out-of-hospital cardiac arrest.
The investigators will study 10 cardiac arrest patients, and participants will be given the ketone drink via a feeding tube (which is routinely passed into the stomach in such cases). The investigators shall check that the drink is absorbed, and measure the ketone levels in the blood. The investigators will also measure important aspects of blood chemistry (including pH and blood sugar) and collect data on brain (electrical recordings called 'EEG' and 'SSEP') and heart function (ultrasound scans or 'echocardiographs') - both of which it is hoped might improve - in order to demonstrate that this is possible if it is to be included in a subsequent large trial. The study will be scrutinised by world experts in the field, who have also helped design the study.
If this pilot study is a success, the investigators will apply to a major grant body to fund an appropriately-powered randomised controlled trial to determine whether ketones improve neurological outcome and survival in these patients. Results will also allow similar studies to be planned in heart attack, stroke and traumatic brain injury.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sally Burtles, Dr
- Phone Number: 02078827260
- Email: sponsorsrep@bartshealth.nhs.uk
Study Locations
-
-
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London, United Kingdom
- Barts Heart Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 18 years or above
- Male or female
- Comatose survivors of out-of-hospital cardiac arrest, defined as return of spontaneous circulation for at least 5 minutes with a score of <8 on the Glasgow Coma Scale
- For admission to intensive care unit for full, active treatment
Exclusion Criteria:
- Primary neurological or intracranial cause of cardiac arrest
- In-hospital cardiac arrest
- Inclusion in another trial at time of recruitment
- Over 4 hours from time of return of spontaneous circulation to enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Ketone ester drink to be administered by nasogastric tube.
Initial bolus dose of 25 ml on enrollment.
After 1 hour, begin 47 hr infusion at 6 ml per hour.
|
Ketone ester drink
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline arterial blood gas values for pH
Time Frame: 48 hours
|
48 hours
|
|
Change from baseline arterial blood gas value for bicarbonate (mmol/L),
Time Frame: 48 hours
|
48 hours
|
|
Change from baseline arterial blood gas value for base excess (mEq/L),
Time Frame: 48 hours
|
48 hours
|
|
Change from baseline arterial blood gas value for glucose (mmol/L)
Time Frame: 48 hours
|
48 hours
|
|
Change from baseline arterial blood gas value for lactate (mmol/L)
Time Frame: 48 hours
|
48 hours
|
|
Change from baseline biochemistry laboratory results (full biochemistry panel including lipids, non-esterified fatty acids and serum insulin as per study protocol)
Time Frame: 48 hours
|
48 hours
|
|
Change from baseline haematology laboratory results (full blood count and coagulation profile as per study protocol)
Time Frame: 48 hours
|
48 hours
|
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Time from arrival of participant to ketone drink administration (hh:mm)
Time Frame: 24 hours
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24 hours
|
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Number of participants receiving full course of ketone drink
Time Frame: 48 hours
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As defined in study protocol: 25ml bolus followed after 1 hour by 47 hour infusion at 6 ml per hour
|
48 hours
|
Change from baseline serum troponin (ng/ml)
Time Frame: 12 hours
|
12 hours
|
|
Change from baseline serum neuron specific enolase (ng/ml)
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline level of plasma betahydroxybutyrate (mmol/L)
Time Frame: 48 hours
|
48 hours
|
Number of participants undergoing electroencephalogram as per protocol
Time Frame: 72 hours
|
72 hours
|
Number of participants undergoing somatosensory evokes potentials as per protocol
Time Frame: 72 hours
|
72 hours
|
Number of participants undergoing echocardiography as per protocol
Time Frame: 72 hours
|
72 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ajay Jain, MBBS MD, Consultant Cardiologist
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 011774
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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