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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,008
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 decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.
Xiangya hospital，Central South University
Changsha, Hunan, China
RECRUITINGFavorable neurological prognosis
Assessed using the CPC score, with a score of 1-2 being a favorable outcome.
Time frame: 90 days post cardiac arrest
GCS score
GCS score
Time frame: 7 days post cardiac arrest
CPC score
CPC score
Time frame: 1 day (discharge date)
GCS score
GCS score
Time frame: 1 day (discharge date)
Time to death
Number of days alive within 180 days from ROSC.
Time frame: 180 days
the length of ICU stay
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
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
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
The incidence of adverse effects during ICU treatment
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
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
28-day mortality
Time frame: 28 days post cardiac arrest
Quality of life assessment
Health-related Quality of Life - EQ-5D (Index value)
Time frame: 90 days post cardiac arrest
bundle compliance rate
referring to the proportion of patients whose management parameters are within the target ranges.
Time frame: 72 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.