Infusion of sodium lactate after cardiac arrest
Hypertonic Lactate After Cardiac Arrest
This study is testing if giving a special solution called sodium lactate to patients who have just been revived from cardiac arrest can help protect their brain and reduce damage.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasme University Hospital Academic / other |
| Locations | 1 site (Brussels, Belgium) |
| Trial ID | NCT05004610 on ClinicalTrials.gov |
What this trial studies
This phase II clinical trial aims to evaluate the safety and efficacy of hypertonic sodium lactate (HSL) infusion in patients who have been resuscitated from cardiac arrest. The study will involve comatose patients who will be randomized to receive either HSL infusion or standard care for 24 hours. The primary outcome will be the measurement of serum biomarkers related to brain damage, specifically NSE, to assess the potential reduction in organ damage. The trial seeks to provide foundational data for future larger studies.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced a sustained return of spontaneous circulation after cardiac arrest and are comatose.
Not a fit: Patients with traumatic cardiac arrest or those who are expected to have life support withdrawn within 24 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce brain damage and improve outcomes for patients resuscitated from cardiac arrest.
How similar studies have performed: Previous studies have shown some benefits of hypertonic sodium lactate in related conditions, but this specific approach in post-cardiac arrest patients is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years old * Sustained (\> 20 minutes) return of spontaneous circulation (ROSC) * Comatose (GCS \< 9) * Time to ROSC \> 15' Exclusion Criteria: * Protected categories (Pregnant women) * Anticipated withdrawal of support within 24 hours * Traumatic cause of cardiac arrest * Body weight at admission \> 120Kg
Where this trial is running
Brussels, Belgium
- Erasme Hospital, Brussels University Hospital (HUB) — Brussels, Belgium, Belgium (Recruiting)
Study contacts
- Principal investigator: Filippo Annoni, MD — Erasme University Hospital
- Study coordinator: Filippo Annoni, MD
- Email: filippo.annoni@erasme.ulb.ac.be
- Phone: 0483141483
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.