Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

  • Goal-directed care bundle for neuroprotection

    Other intervention

    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

    Other intervention

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

Treatment groups

1,008 Participants
are divided into 2 treatment groups
Group A: Goal-directed care bundle for neuroprotectionOther 1 intervention
Group B: Usual care groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Favorable neurological prognosis

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

Time frame
90 days post cardiac arrest

Secondary outcomes

1

GCS score

GCS score

Time frame
7 days post cardiac arrest
2

CPC score

CPC score

Time frame
1 day (discharge date)
3

GCS score

GCS score

Time frame
1 day (discharge date)
4

Time to death

Number of days alive within 180 days from ROSC.

Time frame
180 days

Other outcomes

Sponsors and contacts

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