Ketone drink after cardiac arrest pilot v1

  • Research type

    Research Study

  • Full title

    Feasibility and safety of delivering a ketone drink to comatose survivors of out-of-hospital cardiac arrest

  • IRAS ID

    204774

  • Contact name

    Ajay Jain

  • Contact email

    ajay.jain@bartshealth.nhs.uk

  • Sponsor organisation

    Barts Health NHS Trust/Queen Mary University London

  • Clinicaltrials.gov Identifier

    NCT03226197

  • Duration of Study in the UK

    0 years, 6 months, 2 days

  • Research summary

    In the UK approximately 30,000 patients suffer cardiac arrest (the heart stopping) outside of the hospital environment every year. Of these, around 6,350 are subsequently treated on an intensive care unit, 46% of whom die due to neurological (brain) injury. Around 50% of intensive care unit survivors will suffer long-term neurological impairment. Apart from controlling patients’ temperatures, there are no known treatments to protect the brain or improve outcome.\n\n’Ketone bodies’ are naturally produced by the human body under conditions of starvation. There is evidence from human and animal studies that ketone bodies may help to protect tissues, including the brain, during or shortly after periods of reduced oxygen supply, such as cardiac arrest.\n\nKetone bodies have now been manufactured, and have been safely used in ’drink’ form by athletes for many years. We aim to investigate whether giving a ketone drink to patients admitted to hospital after cardiac arrest will improve their outcomes. This pilot study will assess the practicalities and safety of giving a ketone drink to these patients. The drink will be given through a feeding tube inserted into a patient’s stomach via their nose.\n\nAdult patients presenting to hospital after an out-of-hospital cardiac arrest would be eligible. The study will be conducted at a single site and will recruit 10 participants. The study will last 72 hours for each participant. The intervention will include the placement of a feeding tube via the nose into the stomach (a part of standard care) with a ketone drink given via this tube for 48 hours. The dose used is safe in normal individuals, with effective absorption via this tube route. During this period blood samples will be taken to assess any ill-effects. Patients will also have non-invasive tests of the heart, brain and nervous system between 24 and 72 hours after admission.

  • REC name

    South Central - Berkshire Research Ethics Committee

  • REC reference

    17/SC/0417

  • Date of REC Opinion

    20 Sep 2017

  • REC opinion

    Further Information Favourable Opinion