NCT07239908 Resuscitation Enhancement to Avoid Rearrest Through Evidence-based Strategies in Prehospital Post-resuscitation Care
| NCT ID | NCT07239908 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Siriraj Hospital |
| Condition | Out-of-hospital Cardiac Arrest (OHCA) |
| Study Type | INTERVENTIONAL |
| Enrollment | 318 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 318 participants in total. It began in 2025-12-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Out-of-hospital cardiac arrest (OHCA) remains a leading global emergency condition with low survival to hospital discharge despite advances in cardiopulmonary resuscitation. Return of spontaneous circulation (ROSC) rates have improved; however, 30-50% of patients experience rearrest after ROSC, which is associated with significantly reduced survival. Preventable physiologic factors related to prehospital care - including hypoxia, hypotension, and hyperventilation - are frequently identified prior to rearrest. Evidence-based post-ROSC clinical bundles exist mainly for in-hospital settings, while structured prehospital post-resuscitation care protocols are limited, particularly in resource-constrained environments. The RE-ARREST project aims to develop, implement, and evaluate an evidence-based prehospital post-resuscitation care protocol designed for paramedic-led Emergency Medical Services. The intervention includes structured monitoring, tailored oxygenation and ventilation targets, vasopressor use criteria (norepinephrine), fluid management decision support, teamwork communication, and operational training workshops using simulation. This is a quasi-experimental pre-post interventional study conducted at the Siriraj Emergency Medical Service (SiEMS), Thailand. The study compares outcomes from retrospective pre-implementation cases with prospective post-implementation cases, including both patient-centered outcomes and provider compliance. Adult OHCA patients with ROSC achieved prehospital and transported to Siriraj Hospital are eligible. The estimated sample size is 318 participants (pre-intervention 212; post-intervention 106) over two years. The primary outcome is the incidence of rearrest within 1 hour after ROSC during prehospital care and initial emergency department management. Secondary outcomes include protocol compliance, survival-to-admission, and survival-to-hospital-discharge. The protocol emphasizes feasibility, safety, and replicability to inform scalable EMS clinical practice guidelines. This research is expected to provide novel evidence on targeted prehospital post-ROSC care and has the potential to reduce rearrest, improve neurologically favorable survival, and strengthen EMS system quality improvement efforts in Thailand and other low-to-middle-resource settings.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years or older. * Patients with out-of-hospital cardiac arrest (OHCA) who received resuscitative care from the Siriraj Emergency Medical Services Center (SiEMS). Patients who achieved return of spontaneous circulation (ROSC) prior to hospital arrival. \- Patients subsequently transported to the Emergency Department of Siriraj Hospital for further treatment. Exclusion Criteria: * Suspected traumatic cardiac arrest. * ROSC patients whose legally authorized representative declined vasopressor administration, despite clinical indication according to the prehospital post-resuscitation care protocol. * ROSC patients who had not undergone endotracheal intubation, and whose legally authorized representative declined endotracheal intubation, despite protocol-based indication. * ROSC patients without rearrest whose legally authorized representative declined further blood investigations or additional procedures after arrival at the Emergency Department. * Patients whose legally authorized representative declined participation in the study. * Patients without an available legally authorized representative to provide consent for study participation.
Contact & Investigator
Sattha Riyapan, MD MPH
PRINCIPAL INVESTIGATOR
Mahidol University
Frequently Asked Questions
Who can join the NCT07239908 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Out-of-hospital Cardiac Arrest (OHCA). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07239908 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07239908 currently recruiting?
Yes, NCT07239908 is actively recruiting participants. Contact the research team at sattha.riy@mahidol.ac.th for enrollment information.
Where is the NCT07239908 trial being conducted?
This trial is being conducted at Bangkok Noi, Thailand.
Who is sponsoring the NCT07239908 clinical trial?
NCT07239908 is sponsored by Siriraj Hospital. The principal investigator is Sattha Riyapan, MD MPH at Mahidol University. The trial plans to enroll 318 participants.