Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest

NCT ID: NCT06992843

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1008 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-22
• Study Completion Date: 2027-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Goal-directed care bundle for neuroprotection

Management policy to receive a goal-directed care bundle that involves the rapid correction (\<24 hour) of physiological variables as soon as the abnormality is recognised and for the control to be maintained in patients for 72h or hospital discharge (or death, if sooner)

Group Type: OTHER

Goal-directed care bundle for neuroprotection

Intervention Type: OTHER

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.

Usual care group

Patients receive the usual management based on local guidelines and hospital's individual policy.

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years and < 80 years
• Patients of in-hospital or out-of-hospital cardiac arrest who have returned -spontaneous circulation (ROSC) after cardiopulmonary resuscitation and do not require CPR for more than 20 minutes;
• Patients who are unconscious after ROSC, defined as FOUR motor response score < 4 points or GSC ≤ 8 points;
• Family members or legal representatives signed informed consent.

Exclusion Criteria

• Unwitnessed cardiac arrest, estimated time from cardiac arrest to start of CPR > 30 minutes;
• Time from cardiac arrest to ROSC > 60 minutes;
• Patients who woke up immediately after ROSC by CPR;
• End-stage diseases;
• Cardiac arrest considered to be caused by neurological diseases;
• The patient was in a vegetative state before cardiac arrest;
• The interval from the onset of cardiac arrest to enrollment is >72 hours .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

icuzhanglina

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Xiangya hospital，Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lina Zhang

Role: CONTACT

zln7095@163.com

86+15874875763

Facility Contacts

Zheren Tan, Phd

Role: primary

tanzheren@126.com

86+15616244605

Other Identifiers

2024121757

Identifier Type: -

Identifier Source: org_study_id