Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation (HypoLungECMO)

Central Hospital, Nancy, France

Status: Not yet enrolling

Conditions: Extracorporeal Membrane Oxygenation Complication; ARDS, Human; Hypothermia

Treatments: Device: Normothermia; Device: Moderate Hypothermia

Study type: Interventional

Funder types: Other

Identifiers

NCT05306392

2022-A00168-35

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Moderate Hypothermia

Experimental group

Description:

Patients with acute respiratory distress syndrome treated with venovenous ECMO to a strategy of moderate hypothermia during 48 hours (Temperature at 33°C≤ T°C ≤34°C) associated with usual care

Treatment:

Device: Moderate Hypothermia

Control - Normothermia

Sham Comparator group

Description:

Patients with acute respiratory distress syndrome treated with venovenous ECMO to a strategy of normothermia (36°C≤ T°C ≤37°C) associated with usual care

Treatment:

Device: Normothermia