Out-Of-Hospital Cardiac ArrestNCT03226197
Feasibility and Safety of Delivering a Ketone Drink to Comatose Survivors of Out-of-hospital Cardiac Arrest
A study testing Ketone ester drink in people with Out-Of-Hospital Cardiac Arrest, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest
- What is being tested?
- Ketone ester drink
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Mar 2018to 13 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Over 4 hours from time of return of spontaneous circulation to enrollment
Who cannot join
- Primary neurological or intracranial cause of cardiac arrest
- In-hospital cardiac arrest
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Being tested
- Ketone ester drink
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone ester drinkDietary supplement
Ketone ester drink
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Dietary Supplement: Ketone ester drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline arterial blood gas values for pH
Measured: 48 hours
Change from baseline arterial blood gas value for bicarbonate (mmol/L),
Measured: 48 hours
Change from baseline arterial blood gas value for base excess (mEq/L),
Measured: 48 hours
Change from baseline arterial blood gas value for glucose (mmol/L)
Measured: 48 hours
Change from baseline arterial blood gas value for lactate (mmol/L)
Measured: 48 hours
Change from baseline biochemistry laboratory results (full biochemistry panel including lipids, non-esterified fatty acids and serum insulin as per study protocol)
Measured: 48 hours
Change from baseline haematology laboratory results (full blood count and coagulation profile as per study protocol)
Measured: 48 hours
Time from arrival of participant to ketone drink administration (hh:mm)
Measured: 24 hours
Number of participants receiving full course of ketone drink
As defined in study protocol: 25ml bolus followed after 1 hour by 47 hour infusion at 6 ml per hour
Measured: 48 hours
Change from baseline serum troponin (ng/ml)
Measured: 12 hours
Change from baseline serum neuron specific enolase (ng/ml)
Measured: 48 hours
Secondary outcomes (4)
Change from baseline level of plasma betahydroxybutyrate (mmol/L)
Measured: 48 hours
Number of participants undergoing electroencephalogram as per protocol
Measured: 72 hours
Number of participants undergoing somatosensory evokes potentials as per protocol
Measured: 72 hours
Number of participants undergoing echocardiography as per protocol
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start14 Mar 2018
- Primary completion13 Sep 2019
- Study completion13 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Ajay Jain, MBBS MD, Principal investigator, Consultant Cardiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226197
- Sponsor's protocol ID
- 011774
- Status last verified
- May 2025
- First submitted
- 12 Jul 2017
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Delivering a Ketone Drink to Comatose Survivors of Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03226197
- Acronym / sponsor ID
- 011774
- Conditions
- Out-Of-Hospital Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 14 Mar 2018 (actual)
- Primary completion
- 13 Sep 2019 (actual)
- Study completion
- 13 Sep 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Dietary Supplement: Ketone ester drinkKetone 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- Over 4 hours from time of return of spontaneous circulation to enrollment
Key exclusion criteria (2 listed)
- Primary neurological or intracranial cause of cardiac arrest
- In-hospital cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketone ester drinkKetone ester drink | Dietary supplement | Study group |
Primary outcome
Change from baseline arterial blood gas values for pH
Time frame: 48 hours
Change from baseline arterial blood gas value for bicarbonate (mmol/L),
Time frame: 48 hours
Change from baseline arterial blood gas value for base excess (mEq/L),
Time frame: 48 hours
Change from baseline arterial blood gas value for glucose (mmol/L)
Time frame: 48 hours
Change from baseline arterial blood gas value for lactate (mmol/L)
Time frame: 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
Change from baseline haematology laboratory results (full blood count and coagulation profile as per study protocol)
Time frame: 48 hours
Time from arrival of participant to ketone drink administration (hh:mm)
Time frame: 24 hours
Number of participants receiving full course of ketone drink
Time frame: 48 hours
As defined in study protocol: 25ml bolus followed after 1 hour by 47 hour infusion at 6 ml per hour
Change from baseline serum troponin (ng/ml)
Time frame: 12 hours
Change from baseline serum neuron specific enolase (ng/ml)
Time frame: 48 hours
4 secondary outcomes
Change from baseline level of plasma betahydroxybutyrate (mmol/L)
Time frame: 48 hours
Number of participants undergoing electroencephalogram as per protocol
Time frame: 72 hours
Number of participants undergoing somatosensory evokes potentials as per protocol
Time frame: 72 hours
Number of participants undergoing echocardiography as per protocol
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
Related trials for Out-Of-Hospital Cardiac Arrest
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
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Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ajay Jain, MBBS MD principal investigator
Consultant Cardiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone ester drink in people with Out-Of-Hospital Cardiac Arrest, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline arterial blood gas values for pH (time frame: 48 hours). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.