Feasibility and Safety of Delivering a Ketone Drink to Comatose Survivors of Out-of-hospital Cardiac Arrest

July 25, 2023 updated by: Richard Armstrong, Barts & The London NHS Trust

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

Suspended

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
Time from arrival of participant to ketone drink administration (hh:mm)
Time Frame: 24 hours
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
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ajay Jain, MBBS MD, Consultant Cardiologist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2018

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 20, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 011774

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Out-Of-Hospital Cardiac Arrest

Clinical Trials on Ketone ester drink

3
Subscribe