Feasibility & Safety of Delivering a Ketone Drink to Comatose Survivors of

Status Suspended

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03226197
Study type	Interventional
Source	Barts & The London NHS Trust
Contact
Status	Suspended
Phase	N/A
Start date	March 14, 2018
Completion date	December 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05434910` - Blood Pressure and Cerebral Blood Flow After Cardiac Arrest	N/A
Active, not recruiting	`NCT03700125` - Pre-hospital ECMO in Advanced Resuscitation in Patients With Refractory Cardiac Arrest. ( SUB30 )	N/A
Completed	`NCT02527694` - CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA	N/A
Completed	`NCT02899507` - Prophylactic Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest	Phase 4
Recruiting	`NCT02184468` - Survival Study After Out-of-hospital Cardiac Arrest	N/A
Completed	`NCT04085692` - Dispatcher-Assisted CPR: Low-Dose, High-Frequency Simulation-Based Training	N/A
Recruiting	`NCT05029167` - REstrictive Versus LIberal Oxygen Strategy and Its Effect on Pulmonary Hypertension After Out-of-hospital Cardiac Arrest (RELIEPH-study)	N/A
Completed	`NCT04080986` - DOuble SEquential External Defibrillation for Refractory VF	N/A
Completed	`NCT04058925` - Tissue Oxygenation During Cardiopulmonary Resuscitation as a Predictor of Return of Spontaneous Circulation
Enrolling by invitation	`NCT05113706` - Does Bystanders Emotional State Influence Dispatcher-assisted Cardiopulmonary?Resuscitation
Completed	`NCT04219306` - Machine Learning Assisted Recognition of Out-of-Hospital Cardiac Arrest During Emergency Calls.	N/A
Completed	`NCT03881865` - P25/30 SSEPs and Neurological Prognosis After Cardiac Arrest
Recruiting	`NCT04993716` - Epidemiological Study on the Management of Out-of-hospital Cardiac Arrest Survivors in Champagne ArDEnnes
Completed	`NCT05062785` - Dose-Finding Study of Intranasal Insulin in Healthy Participants Insulin in Healthy Participants	Phase 1
Recruiting	`NCT06122337` - Systemic Evaluation of the Etiologies of Young Adults With Non-traumatic Out-of-hospital Cardiac Arrest
Not yet recruiting	`NCT04584463` - Factors Associated With CPC 1-2 in 110 Patients Admitted in French ICU for a Myocardial Infarction Complicated by an OHCA.
Recruiting	`NCT03355885` - Early-onset Pneumonia After Out-of-hospital Cardiac Arrest	N/A
Recruiting	`NCT05132387` - Wroclaw Out-Of-Hospital Cardiac Arrest Registry
Not yet recruiting	`NCT05969028` - First Responder Airway & Compression Rate Trial	N/A
Not yet recruiting	`NCT06046339` - Left Ventricular Ejection Fraction in Cardiac Arrest Survivors Treated With Extracorporeal Cardiopulmonary Resuscitation

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms