NCT06992843

Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest

A Multicenter, Prospective, Stepped Wedge Cluster Randomized Controlled Study on the Effect of Neuroprotection Bundles on the Improvement of Neurological Outcomes After Cardiopulmonary Resuscitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,008 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The investigators designed LAPTOPS to determine the effectiveness of a goal-directed neuroprotection bundles of active management including body temperature,PaCO2,PaO2,position,Blood glucose ,blood sodium,Blood pressure and Lactate vs. usual care in adult post-cardiac arrest care. LAPTOPS is a large-scale pragmatic clinical trial to provide reliable evidence over the effectiveness of a widely applicable goal-directed care bundle in acute phase of adult post-cardiac arrest care.

Conditions

• Cardiac Arrest
• Post-cardiac Arrest Care

Interventions

Type	Name	Description
OTHER	Goal-directed care bundle for neuroprotection	Reducing lactate (Lac) to \<2 mmol/L within 24 hours.Maintaining systolic arterial pressure at 120-140 mmHg. Elevating the head-of-bed to 30 degrees. Maintaining body temperature ≤37.7°C. Maintaining PaO₂ at 70-100 mmHg. Maintaining PaCO₂ at 35-45 mmHg. Maintaining blood glucose at 7.8-10.0 mmol/L. Maintaining serum sodium level at 140-150 mmol/L. If any management parameter falls outside the target range, immediate correction is required within 24 hours of enrollment and must be sustained for 72 hours. Given the dynamic nature of some targets (e.g., mean arterial pressure, body temperature), a degree of flexibility is permitted in achieving these goals. Patients are considered to have successfully implemented the neuroprotection bundle if the achievement rate of individual targets is ≥80% and all targets are met. The medications(antipyretics, vasopressor agents) is acceptable to achieve these targets.
OTHER	Usual Care	Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.

Timeline

• Start date: 2025-10-22
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2025-05-28
• Last updated: 2025-11-18

Locations

1 site across 1 country: China