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

Out-Of-Hospital Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03226197
• Other study ID #: 011774
• Status: Suspended
• Phase: N/A
• Start date: March 14, 2018
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest

Intervention

Dietary Supplement:
• Ketone ester drink
Ketone ester drink

Locations

Country	Name	City	State
United Kingdom	Barts Heart Centre	London

Sponsors (2)

Lead Sponsor	Collaborator
Barts & The London NHS Trust	University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline arterial blood gas values for pH		48 hours
Primary	Change from baseline arterial blood gas value for bicarbonate (mmol/L),		48 hours
Primary	Change from baseline arterial blood gas value for base excess (mEq/L),		48 hours
Primary	Change from baseline arterial blood gas value for glucose (mmol/L)		48 hours
Primary	Change from baseline arterial blood gas value for lactate (mmol/L)		48 hours
Primary	Change from baseline biochemistry laboratory results (full biochemistry panel including lipids, non-esterified fatty acids and serum insulin as per study protocol)		48 hours
Primary	Change from baseline haematology laboratory results (full blood count and coagulation profile as per study protocol)		48 hours
Primary	Time from arrival of participant to ketone drink administration (hh:mm)		24 hours
Primary	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	48 hours
Primary	Change from baseline serum troponin (ng/ml)		12 hours
Primary	Change from baseline serum neuron specific enolase (ng/ml)		48 hours
Secondary	Change from baseline level of plasma betahydroxybutyrate (mmol/L)		48 hours
Secondary	Number of participants undergoing electroencephalogram as per protocol		72 hours
Secondary	Number of participants undergoing somatosensory evokes potentials as per protocol		72 hours
Secondary	Number of participants undergoing echocardiography as per protocol		72 hours