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Recruiting NCT06992843

Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest

No phase Interventional Cardiac Arrest Post-cardiac Arrest Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Goal-directed care bundle for neuroprotection, Usual Care.
Who it may be relevant to
Registry conditions: Cardiac Arrest, Post-cardiac Arrest Care. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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
  • 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.

Primary outcome measures

  • Favorable neurological prognosis [Time frame: 90 days post cardiac arrest]
Secondary outcome measures (12)
  • GCS score [Time frame: 7 days post cardiac arrest]
  • CPC score [Time frame: 1 day (discharge date)]
  • GCS score [Time frame: 1 day (discharge date)]
  • Time to death [Time frame: 180 days]
  • the length of ICU stay [Time frame: 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.]
  • the length of hospital stay [Time frame: 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.]
  • the length of mechanical ventilation [Time frame: 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.]
  • the incidence of adverse event [Time frame: 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.]
  • in-hospital mortality [Time frame: 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.]
  • 28-day mortality [Time frame: 28 days post cardiac arrest]
  • Quality of life assessment [Time frame: 90 days post cardiac arrest]
  • bundle compliance rate [Time frame: 72 hours]

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 .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Xiangya hospital，Central South University — Changsha

Identifiers

NCT: NCT06992843 · 2024121757

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗