Impact on Lactate Clearance of Early Hemodynamic Optimization Through Pleth Variability Index in the ED for Resuscitated Out-of-hospital Cardiac Arrests
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Change of lactate
研究概览
简要总结
Less than half of the patients suffering from sudden cardiac arrest arrive at the hospital alive. Within these survivors less than half will be discharged alive from the hospital without being severely disabled.
The most frequent cause of death during the first 24 hours since admission to the hospital is related to cardiovascular instability and failure. In the early phases of ROSC patients are hemodynamically unstable and management for out of hospital cardiac arrests relies on few non invasive measurements such as non invasive blood pressure, SatO2, EtCO2 and continuous ECG. Recent technological advances allow continuous non invasive evaluation of response to fluid challenge in mechanically ventilated patients through the pleth variability index.
The investigators hypothesize that early goal directed therapy based on non invasive measurement of the pleth variability index on top of conventional non-invasive monitor during the initial care in the Emergency Department can improve the hemodynamic status of the participants, increase lactate clearance and reduce fluid balance at 48 hours post arrest.
Objectives:
- To determine whether an early goal directed management based on the pleth variability index on top of standard non invasive hemodynamic monitoring could improve the hemodynamic status of patients post cardiac arrest especially in terms of increase in lactate clearance and reduced fluid balance. Neurological outcome will be investigated.
详细描述
Less than half of the patients suffering from sudden cardiac arrest arrive at the hospital alive. Of these survivors less than half will be discharged alive from the hospital without being severely disabled.
The most frequent cause of death during the first 24 hours since admission to the hospital is related to cardiovascular instability and failure. In the early phases of ROSC from out of hospital cardiac arrest patients are hemodynamically unstable and management relies on few non invasive measurements such as non invasive blood pressure, SatO2, EtCO2 and continuous ECG.
Even at arrival at the ER patients are monitored by non-invasive parameters during the early phases and invasive hemodynamic monitoring may be delayed until ICU admission. Recent technological advances allow continuous non invasive evaluation of response to fluid challenge in mechanically ventilated patients through the pleth variability index.
The research proposal by the investigator is a randomized prospective interventional, single-center study based at Saint Pierre University Hospital, carried out in the emergency department.
Participant will be OHCA admitted alive to the Emergency department with unstable hemodynamics defined as a mean systolic pressure below 70 mmHg or a blood lactate concentration of at least 36 mg/dL (4 mmol/L).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out of Hospital Cardiac Arrest
- •ROSC before Emergency department admission
- •Mecanically ventilated with a tidal volume of at least 6 ml/IBW
- •Admitted to the emergency department with a lactate > 4mmol/L or a mean arterial pressure below 65 mmHg or a TRC>5 seconds
排除标准
- •Prisoners
- •Pregnant woman
- •Atrial fibrillation
研究组 & 干预措施
Pleth Variability Index
In the experimental group patients will be hemodynamically resuscitated in the early phases after ROSC based on the pleth variability index on top of standard non invasive monitoring
干预措施: Pleth variability index (Device)
Standard non invasive monitoring
In the control group patients will be hemodynamically resuscitated in the early phases after ROSC based on standard non invasive monitoring such as SatO2, EtCO2, non invasive blood pressure and continuous ECG.
干预措施: Standard non invasive monitoring (Device)
结局指标
主要结局
Change of lactate
时间窗: From ED admission until 6 hours from admission with 1 predefined time point at 3 hours from ED admission
Change of lactate at 3h from admission. Lactate clearance will be measured as {(Admission lactate \[mmol/L\] - Lactate at time point \[mmol/L\]) / (Admission lactate \[mmol/L\])} x 100
次要结局
- Mortality 72h(72 hours)
- Mortality 24h(24 hours)
- Change of lactate(From ED admission until 24 hours from admission with 3 predefined time points at 6,12 and 24 hours from ED admission)
- Fluid balance first 48 hours(48 hours)
- Fluid balance first 24 hours(24 hours)
- SOFA 24 hours(24 hours)
- CPC at hospital discharge(At 16 weeks or at hospital discharge whichever comes first)
- Normalization of lactate(48 hours)
研究者
Stefano Malinverni, MD
Consultant Academic Doctor
Centre Hospitalier Universitaire Saint Pierre