Cardiac Arrest, Post-cardiac Arrest Care
Conditions
Keywords
post-cardiac arrest care, neuroprotection, cardiac arrest, Care Bundle, Clinical Trial, Stepped-wedge Cluster
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.
Interventions
OTHERGoal-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 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.
OTHERUsual Care
Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Stepped-wedge Cluster Randomised Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Favorable neurological prognosis | 90 days post cardiac arrest | Assessed using the CPC score, with a score of 1-2 being a favorable outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CPC score | 1 day (discharge date) | CPC score |
| Time to death | 180 days | Number of days alive within 180 days from ROSC. |
| 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. | the length of ICU stay |
| the length of hospital stay | 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 hospital stay |
| the length of mechanical ventilation | 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 length of mechanical ventilation |
| GCS score | 7 days post cardiac arrest | GCS score |
| in-hospital mortality | 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. | in-hospital mortality |
| 28-day mortality | 28 days post cardiac arrest | 28-day mortality |
| Quality of life assessment | 90 days post cardiac arrest | Health-related Quality of Life - EQ-5D (Index value) |
| bundle compliance rate | 72 hours | referring to the proportion of patients whose management parameters are within the target ranges. |
| the incidence of adverse event | 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 incidence of adverse effects during ICU treatment |
Countries
China
Contacts
Primary ContactLina Zhang
Outcome results
None listed