Clinical trial NCT06992843: Neuroprotection Bundles Comatose Survivors for in Cardiac Arrest Trial
Official title: A Multicenter, Prospective, Stepped Wedge Cluster Randomized Controlled Study on the Effect of Neuroprotection Bundles on the Improvement of Neurological Outcomes After Cardiopulmonary Resuscitation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Arrest
Post-cardiac Arrest Care
Keywords: post-cardiac arrest care
neuroprotection
cardiac arrest
Care Bundle
Clinical Trial
Stepped-wedge Cluster
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2025-05-28
Enrollment: 1008
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge Cluster Randomised Trial
Primary purpose: TREATMENT

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.


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 .

Primary outcomes:
measure: Favorable neurological prognosis
timeFrame: 90 days after enrollment
Secondary outcomes:
measure: GCS score
timeFrame: 7 days
measure: CPC score
timeFrame: 1 day (discharge date)
measure: GCS score
timeFrame: 1 day (discharge date)
measure: Time to death
timeFrame: 180 days
measure: the length of ICU stay
timeFrame: 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.
measure: the length of hospital stay
timeFrame: The total length of hospital-stay will be determined from the date of ICU admission until the patient is discharged from the hospital or the date of death from any cause assessed up to 1 year after the first day of admission.
measure: the length of mechanical ventilation
timeFrame: Total ventilation time during ICU stay will be determined when the patient is discharged from the ICU or when the patient past away from any cause, assessed up to 1 year after the first day of admission.
measure: the incidence of adverse event
timeFrame: 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.
measure: in-hospital mortality
timeFrame: The total length of hospital-stay will be determined from the date of ICU admission until the patient is discharged from the hospital or the date of death from any cause assessed up to 1 year after the first day of admission.
measure: 28-day mortality
timeFrame: 28 days after enrollment
measure: Quality of life assessment
timeFrame: 90 days after enrollment
measure: bundle compliance rate
timeFrame: 72 hours
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya hospital，Central South University
state: Hunan
Study officials:
References: