NCT04990349已完成3 期
Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation : Impact on Organ Dysfunction in Patients Supported by Veino-arterial ECMO for Cardiogenic Shock
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Enterocyte damage
研究概览
简要总结
Because of dual oxygenation and oxygenator performance (PO2 postoxygenator up to 500 mmHg), hyperoxemia (PaO2 > 150 mmHg) is frequent in veino-arterial ECMO, especially in the lower part of the body, which is mainly oxygenated by ECMO.
By enhancing oxygen free radicals' production, hyperoxemia might favor gut, kidney and liver dysfunction.
We hypothesize that targeting an extracorporeal normoxemia (i.e. PO2 postoxygenator between 100 and 150 mmHg) will decrease gut, kidney and liver dysfunctions, compared to a liberal extracorporeal oxygenation.
详细描述
Randomization:
Patients will be randomized in the 6 hours following ECMO start in the normoxemia or in the hyperoxemia group. Randomization will be stratified on center, and medical or postcardiotomy indication for ECMO.
Description of experimental arm (Normoxemia group):
- After randomization, extracorporeal normoxemia is targeted by setting the ECMO membrane oxygen fraction (FmO2) at 60%.
- The objective is to maintain oxygen partial pressure measured on the arterial cannula (PO2 postoxygenator) between 100 and 150 mmHg.
- PO2 postoxygenator is monitored at least twice a day by the nurse.
- If PO2 postoxygenator is less than 100 mmHg or more than 150 mmHg, FmO2 is modified by 10% and PO2 postoxygenator is monitored 10 minutes after.
- Ventilator's settings at let to the clinician's discretion. However, PaO2 on right radial artery will be monitored to ensure that is more that 80 mmHg.
- Intervention will be applied for 7 days after randomization.
Description of the control arm (Hyperoxemia group):
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient supported by veino-arterial ECMO for cardiogenic shock for less than 6 hours
- •Affiliation to social protection
排除标准
- •Age < 18 years old
- •Pregnancy
- •Opposition of the patient or his relatives
- •Cannulation during cardiopulmonary resuscitation
- •Cardiopulmonary resuscitation duration > 10 minutes before ECMO implantation
- •Patient moribound on the day of randomization
- •Chronic hemodialysis
- •Chronic intestinal disease
研究组 & 干预措施
Extracorporeal normoxemia
Experimental
- After randomization, extracorporeal normoxemia is targeted by setting the ECMO membrane oxygen fraction (FmO2) at 60%.
- The objective is to maintain oxygen partial pressure measured on the arterial cannula (PO2 postoxygenator) between 100 and 150 mmHg.
- PO2 postoxygenator is monitored at least twice a day by the nurse.
- If PO2 postoxygenator is less than 100 mmHg or more than 150 mmHg, FmO2 is modified by 10% and PO2 postoxygenator is monitored 10 minutes after.
- Ventilator's setting at let to the clinician's discretion. However, PaO2 on right radial artery will be monitored to ensure that is more that 80 mmHg.
- Intervention will be applied for 7 days after randomization.
干预措施: Oxygen gas (Drug)
Extracorporeal hyperoxemia
Active Comparator
- After randomization, extracorporeal hyperoxemia is targeted by setting the ECMO membrane oxygen fraction (FmO2) at 100%.
- The objective is to maintain PO2 postoxygenator higher than 300 mmHg.
- PO2 postoxygenator is monitored at least twice a day by the nurse.
- If PO2 postoxygenator is less than 300 mmHg, membrane change should be discussed.
- Ventilator's setting at let to the clinician's discretion. However, PaO2 on right radial artery will be monitored to ensure that is more that 80 mmHg.
- Intervention will be applied for 7 days after randomization.
干预措施: Oxygen gas (Drug)
结局指标
主要结局
Enterocyte damage
时间窗: At day 2
Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration
次要结局
- Security of the oxygenation protocol(From day 0 to day 6)
- Enterocyte damage(At day 0, and day 1)
- Liver failure(At day 0, day 2 and day 6)
- Renal failure(From 0 to day 6)
- Feasibility of the oxygenation protocol(From day 0 to day 6)
- Organ failure(At day 0, day 2 and day 6)
- Enterocyte function(At day 0 and day 2)
- Systemic inflammation(At day 0, day 2 and day 6)
- Anti-oxydant stock(At day 0, day 2 and day 6)
研究者
研究点 (1)
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