Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest

NCT06992843 | Recruiting

• 1 other identifier: 2024121757
• Study Type: interventional
• Target: 1,008
• Locations: 1 country
• Sites: 1

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

Keywords

post-cardiac arrest care; neuroprotection; cardiac arrest; Care Bundle; Clinical Trial; Stepped-wedge Cluster

Outcome Measures

Primary Outcomes (1)

• Favorable neurological prognosis

  Assessed using the CPC score, with a score of 1-2 being a favorable outcome.

  90 days post cardiac arrest

Secondary Outcomes (12)

• GCS score

  7 days post cardiac arrest

• CPC score

  1 day (discharge date)

• GCS score

  1 day (discharge date)

• Time to death

  180 days

• the length of ICU stay

  The total length of IC-stay will be determined from the date of ICU admission until the patient is discharged from the Intensive Care Unit or the date of death from any cause, assessed up to 1 year after the first day of admission.

Study Arms (2)

Goal-directed care bundle for neuroprotection

OTHER

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)

Other: Goal-directed care bundle for neuroprotection

Usual care group

OTHER

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

Other: Usual Care

Interventions

Goal-directed care bundle for neuroprotection 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.

Goal-directed care bundle for neuroprotection

Usual Care OTHER

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

Usual care group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya hospital，Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

Neuroprotection

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Lina Zhang

CONTACT

86+15874875763; zln7095@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Stepped-wedge Cluster Randomised Trial

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 28, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)