Evaluation of the Effectiveness of Induced Moderate Hypothermia in the Management of Patients With Severe ARDS Under Venovenous ECMO
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Effectiveness of 48 hours therapeutic hypothermia on the evolution of hypoxemia in patients on VV ECMO
研究概览
简要总结
Acute respiratory distress syndrome (ARDS) is a lesional pulmonary edema that occurs as a result of direct or indirect lung injury. This condition accounts for 10-15% of ICU admissions and 20-25% of patients admitted require invasive ventilation. Its incidence has increased markedly with the Covid-19 epidemic. ARDS is defined as hypoxemia (Pa02/Fi02 < 300 mmHg) in ventilated patients without heart failure. Currently, the recommendations of the resuscitation societies advocate a management combining invasive ventilation, short duration curarization and prone sessions. In case of failure of these therapies, venovenous ExtraCorporeal Membrane Oxygenation (VV ECMO) is recommended in case of Pa02/Fi02 < 80 mmHg.
Nevertheless, approximately 40% of patients have refractory and persistent hypoxemia despite optimization of ECMO parameters and invasive ventilation. The refractory hypoxemia is defined as Pa02 < 55 mmHg and/or Sa02 < 90% and may be due to a recirculation phenomenon or a significant intra-pulmonary shunt. Currently, there is no official recommendation for the management of these patients, leading to the use of various unvalidated field practices. In addition, hospital mortality of the order of 60% is observed in these patients with high management costs.
Some data in the literature suggest that induced therapeutic hypothermia (HT) at 34°C for 48 hours could improve the prognosis of these patients by improving oxygenation. Nevertheless, the level of evidence of published studies remains low because they are either case reviews or studies whose methodology does not guarantee the absence of potential bias.
The research hypothesis is that HT at 34°C or 33°C for 48 hours is effective on refractory hypoxemia.
详细描述
The investigators propose a pilot study, monocentric, prospective, controlled, randomized, to apprehend in an objective and reliable way the effects of induced moderate hypothermia at 34°C, or at 33°C in case of persistence of a Sa02 lower than 90%, during 48 hours in patients under ECMO VV for ARDS. The objective of this study is to show the beneficial effect of the treatment on the patient's oxygenation and to understand the physiopathological mechanism of action at work through different parameters at different times. In parallel, the undesirable effects will be recorded and weighed against the positive effects of the treatment in order to understand the benefit/risk ratio of light HT. The effect on survival will also be evaluated as a secondary objective, not to demonstrate efficacy in this small pilot trial, but to determine the size of the effect that can be expected.
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
- •Patients 18 years of age and older
- •Intubated, ventilated patients with ARDS requiring VV ECMO
- •Family member or trusted person who has been informed about the study and signed the informed consent form or inclusion in an immediate life-threatening situation
- •Benefiting from a Social Security affiliation scheme
排除标准
- •Presence of a recirculation phenomenon (distance between the 2 ECMO cannulas < 10 cm).
- •Patients expected to die within 48 hours of VV ECMO implantation
- •Patients on short-acting beta blockers
- •Pregnant, parturient or lactating woman,
- •Persons deprived of their liberty by a judicial or administrative decision,
- •Minors (non emancipated)
- •Adults subject to legal protection measures (guardianship, curatorship, safeguard of justice).
- •Person undergoing psychiatric care under articles L3212-1 and L3213-1 of the french Public Health Code
结局指标
主要结局
Effectiveness of 48 hours therapeutic hypothermia on the evolution of hypoxemia in patients on VV ECMO
时间窗: between initiation of hypothermia and 48 hours of induced hypothermia
Hypoxemia is measured by arterial saturation of oxygen (expressed in %)
次要结局
- Survival of patients hospitalized in intensive care(Measurement following inclusion with a time maximal of 28 days)
- The number of days without mechanical ventilation during resuscitation hospitalization(Measurement following inclusion with a time maximal of 28 days)
- Effectiveness of 1 hours, 6 hours, 24 hours therapeutic hypothermia on the evolution of hypoxemia in patients on VV ECMO(at 1 hour, 6 hours, 24 hours of the randomization)
- The duration of VV ECMO during hospitalization in the intensive care unit(Measurement following inclusion with a time maximal of 28 days)
- The safety of induced hypothermia treatment during hospitalization in the intensive care unit (infections, coagulation disorders, cardiac risk).(Measurement following inclusion with a time maximal of 28 days)
- Evolution of arterial transport of oxygen during therapeutic hypothermia(Evaluation of arterial transport of oxygen by peripheral gas measurement at 1 hour, 6 hours, 24 hours and 48 hours of hypothermia)
- Evolution of ECMO flow / cardiac output ratio (expressed in %)(Measurement at 1 hour, 6 hours, 24 hours and 48 hours)
- Microcirculatory perfusion and flow variables(at 24 and 48 hours)
研究者
Klein Thomas
Principal investigator
Central Hospital, Nancy, France