Using heart rate variability to predict brain injury after cardiac arrest
Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest
This study is testing if measuring heart rate variability can help doctors predict brain injury in patients who have had a cardiac arrest and are in the ICU.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CMC Ambroise Paré Academic / other |
| Locations | 5 sites (Brest, Brittany Region and 4 other locations) |
| Trial ID | NCT06044922 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of heart rate variability (HRV) as a potential early predictor of noxic brain injury in patients who have experienced cardiac arrest. Patients admitted to the intensive care unit (ICU) after resuscitation will undergo 24-hour Holter monitoring to assess their HRV. The study seeks to improve prognostication in comatose patients following restoration of spontaneous circulation (ROSC) by evaluating HRV alongside existing clinical and paraclinical tests. The goal is to enhance the accuracy of predicting neurological outcomes in these patients.
Who should consider this trial
Good fit: Ideal candidates include patients who are comatose with a Glasgow score of less than 8 after resuscitation from cardiac arrest and require sedation and targeted temperature management.
Not a fit: Patients who are dying, have a non-sinus rhythm, or are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for early identification of patients at risk for severe neurological impairment after cardiac arrest.
How similar studies have performed: While the use of heart rate variability in this context is a novel approach, other studies have explored various prognostic indicators in post-cardiac arrest care with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Admitted in intensive care unit (ICU) after resuscitation from cardiac arrest (in-hospital or out-of-hospital) * Coma (Glasgow score \< 8) after ROSC, requiring sedation and targeted temperature management for at least 24h Exclusion Criteria: * Dying patient (Limitation of life support techniques at admission to the ICU) * Non-Sinus Rhythm * Pregnant or breastfeeding women * Patient under protection of the adults (guardianship, curators or safeguard of justice) * Opposition by the trusted person or by the patient once he/she wakes up
Where this trial is running
Brest, Brittany Region and 4 other locations
- Brest University Hospital — Brest, Brittany Region, France (Recruiting)
- Nantes University Hospital — Nantes, Pays de la Loire Region, France (Recruiting)
- Marseille University Hospital — Marseille, Provence-Alpes-Côte d'Azur Region, France (Recruiting)
- Ambroise Paré - Hartmann Private Hospital Group — Neuilly-sur-Seine, Île-de-France Region, France (Recruiting)
- Cochin Hospital — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Study coordinator: Guillaume GERI, MD, PhD
- Email: guillaume.geri@clinique-a-pare.fr
- Phone: 0146415079
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.