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Completed

NCT Number: 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.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barts Heart Centre

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ketone ester drink

Dietary Supplement

Ketone ester drink

Primary outcomes

  1. Change from baseline arterial blood gas values for pH

    Time frame: 48 hours

  2. Change from baseline arterial blood gas value for bicarbonate (mmol/L),

    Time frame: 48 hours

  3. Change from baseline arterial blood gas value for base excess (mEq/L),

    Time frame: 48 hours

  4. Change from baseline arterial blood gas value for glucose (mmol/L)

    Time frame: 48 hours

  5. Change from baseline arterial blood gas value for lactate (mmol/L)

    Time frame: 48 hours

  6. 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

  7. Change from baseline haematology laboratory results (full blood count and coagulation profile as per study protocol)

    Time frame: 48 hours

  8. Time from arrival of participant to ketone drink administration (hh:mm)

    Time frame: 24 hours

  9. 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

  10. Change from baseline serum troponin (ng/ml)

    Time frame: 12 hours

  11. Change from baseline serum neuron specific enolase (ng/ml)

    Time frame: 48 hours

Secondary outcomes

  1. Change from baseline level of plasma betahydroxybutyrate (mmol/L)

    Time frame: 48 hours

  2. Number of participants undergoing electroencephalogram as per protocol

    Time frame: 72 hours

  3. Number of participants undergoing somatosensory evokes potentials as per protocol

    Time frame: 72 hours

  4. Number of participants undergoing echocardiography as per protocol

    Time frame: 72 hours

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • University College, London

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2017
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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