Neuroprotection Bundles For Comatose Survivors Following Cardiac Arrest

Официальное название

A Multicenter, Prospective, Stepped Wedge Cluster Randomized Controlled Study on the Effect of Neuroprotection Bundles on the Improvement of Neurological Outcomes After Cardiopulmonary Resuscitation

Обзор

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.

Вмешательства

• Другое 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
• Другое Usual Care
  Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.

Первичные конечные точки

• Favorable neurological prognosis [Срок оценки: 90 days post cardiac arrest]

Вторичные конечные точки (12)

• GCS score [Срок оценки: 7 days post cardiac arrest]
• CPC score [Срок оценки: 1 day (discharge date)]
• GCS score [Срок оценки: 1 day (discharge date)]
• Time to death [Срок оценки: 180 days]
• the length of ICU stay [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 28 days post cardiac arrest]
• Quality of life assessment [Срок оценки: 90 days post cardiac arrest]
• bundle compliance rate [Срок оценки: 72 hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 .

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xiangya hospital，Central South University — Чанша

Идентификаторы

NCT: NCT06992843 · 2024121757

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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