2023-506031-15-01招募中2 期
Hypertonic LActaTe afTer cardiac arrEst: the LATTE trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Neuron specific enolase (NSE) plasmatic peak values at 48 hours after return of spontaneous circulation.
研究概览
简要总结
To evaluate the efficacy of hypertonic sodium lactate infusion to decrease brain injury after cardiac arrest in comatose survivors.
研究设计
- 分配方式
- Randomized
- 主要目的
- Main Trial
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years old
- •Sustained return of spontaneous circulation (ROSC) ≥ 20 minutes
- •Comatose state (Glasgow coma scale - GCS < 9)
- •Time to ROSC > 15'
排除标准
- •Pregnant women
- •Anticipated withdrawal of support within 24 hours
- •Traumatic cause of cardiac arrest
- •Body weight at admission > 120 Kg
结局指标
主要结局
Neuron specific enolase (NSE) plasmatic peak values at 48 hours after return of spontaneous circulation.
Neuron specific enolase (NSE) plasmatic peak values at 48 hours after return of spontaneous circulation.
次要结局
- Cerebral performance category score of 1 and 1-2 at 90 days.
- ICU length of stay (days), Hospital length of stay (days).
- Mortality during ICU stay, during hospital stay, at 90 days.
- Vasopressor equivalent dose during the first 48h after resuscitation.
- Seizures episodes during the first 24h, 48h and ICU stay.
- Peak plasmatic concentrations or neurofilament light chain (NFL) at 24, 48 and 72h.
- Peak plasmatic concentrations or glial fibrillary acid protein (GFAP) at 24, 48 and 72h
- Peak plasmatic concentrations or Troponin I (TnI) at 24, 48 and 72h
- Incidence, nature, and severity of adverse events graded according to National Cancer Institute - Common Terminology Criteria for Adverse Events.
研究者
Biomedical research service
Scientific
Hopital Erasme
研究点 (1)
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