Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Goal-directed care bundle for neuroprotection | Other | Management policy to receive a goal-directed care bundle that involves the rapid correction (<24 hour) of physiological variables as soon as the abnormality is recognised and for the control to be maintained in patients for 72h or hospital discharge (or death, if sooner) |
|
| Usual care group | Other | Patients receive the usual management based on local guidelines and hospital's individual policy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Goal-directed care bundle for neuroprotection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Favorable neurological prognosis | Assessed using the CPC score, with a score of 1-2 being a favorable outcome. | 90 days post cardiac arrest |
| Measure | Description | Time Frame |
|---|---|---|
| GCS score | GCS score | 7 days post cardiac arrest |
| CPC score | CPC score | 1 day (discharge date) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lina Zhang | Contact | 86+15874875763 | zln7095@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya hospital,Central South University | Recruiting | Changsha | Hunan | 410000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000066829 | Neuroprotection |
| ID | Term |
|---|---|
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Stepped-wedge Cluster Randomised Trial
Not provided
Not provided
Not provided
|
| Usual Care | Other | Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team. |
|
| GCS score | GCS score | 1 day (discharge date) |
| Time to death | Number of days alive within 180 days from ROSC. | 180 days |
| the length of ICU stay | 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 hospital 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 mechanical ventilation | 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 incidence of adverse event | The incidence of adverse effects during ICU treatment | 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 | 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 | 28 days post cardiac arrest |
| Quality of life assessment | Health-related Quality of Life - EQ-5D (Index value) | 90 days post cardiac arrest |
| bundle compliance rate | referring to the proportion of patients whose management parameters are within the target ranges. | 72 hours |