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

NCT05306392 | Unknown

• 1 other identifier: 2022-A00168-35
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ARDS, Human; Extracorporeal Membrane Oxygenation Complication; Hypothermia

Keywords

Hypothermia; ECMO; Refractory hypoxemia

Outcome Measures

Primary Outcomes (1)

• Effectiveness of 48 hours therapeutic hypothermia on the evolution of hypoxemia in patients on VV ECMO

  Hypoxemia is measured by arterial saturation of oxygen (expressed in %)

  between initiation of hypothermia and 48 hours of induced hypothermia

Secondary Outcomes (8)

• 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

• 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

• Survival of patients hospitalized in intensive care

  Measurement following inclusion with a time maximal of 28 days

• The duration of VV ECMO during hospitalization in the intensive care unit

  Measurement following inclusion with a time maximal of 28 days

Study Arms (2)

Moderate Hypothermia

EXPERIMENTAL

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

Device: Moderate Hypothermia

Control - Normothermia

SHAM COMPARATOR

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

Device: Normothermia

Interventions

Moderate Hypothermia DEVICE

moderate hypothermia will be induced using the heat controller of the VV-ECMO circuit. Temperature will be maintained between 33°C≤ T°C ≤34°C during 48 hours followed by a progressive reheating (0.2±0.1°C/h) to reach 36 °C. Temperature at 36°C will be maintained during 48 hours after having reached 36 °C.

Moderate Hypothermia

Normothermia DEVICE

Temperature at 36°C will be maintained during 48 hours after having reached 36 °C

Control - Normothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age and older
• Intubated, ventilated patients with ARDS requiring VV ECMO
• Benefiting from a Social Security affiliation scheme

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (3)

• Montisci A, Maj G, Zangrillo A, Winterton D, Pappalardo F. Management of refractory hypoxemia during venovenous extracorporeal membrane oxygenation for ARDS. ASAIO J. 2015 May-Jun;61(3):227-36. doi: 10.1097/MAT.0000000000000207.

  PMID: 25923575 RESULT

• Levy B, Taccone FS, Guarracino F. Recent developments in the management of persistent hypoxemia under veno-venous ECMO. Intensive Care Med. 2015 Mar;41(3):508-10. doi: 10.1007/s00134-014-3579-y. Epub 2014 Dec 2. No abstract available.

  PMID: 25447805 RESULT

• Kimmoun A, Vanhuyse F, Levy B. Improving blood oxygenation during venovenous ECMO for ARDS. Intensive Care Med. 2013 Jun;39(6):1161-2. doi: 10.1007/s00134-013-2903-2. Epub 2013 Apr 13. No abstract available.

  PMID: 23584469 RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hypothermia; Hypoxia

Interventions

Hypothermia, Induced

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics

Study Officials

• Bruno LEVY, PhD

  CHRU NANCY, Nancy, France

  STUDY DIRECTOR

• Nathalie THILLY, PhD

  CHRU NANCY, Nancy, France

  STUDY CHAIR

• Thomas KLEIN, MD

  CHRU NANCY, Nancy, France

  STUDY CHAIR

Central Study Contacts

Thomas KLEIN, MD

CONTACT

+33383154045; t.klein@chru-nancy.fr

ludivine ODOUL, Proj man

CONTACT

+33383155580; l.odoul@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Monocentric controlled study, with randomization in two groups (induced hypothermia group and control group), at the Nancy Hospital - Intensive care Unit

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: April 1, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 1, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share