Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation in Patients

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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): - 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. ;

Study Design

Related Conditions & MeSH terms

Cardiogenic Shock
Extracorporeal Membrane Oxygenation
Shock
Shock, Cardiogenic

Clinical Trial Details

NCT number	NCT04990349
Study type	Interventional
Source	Centre Hospitalier Universitaire de Besancon
Contact	Hadrien Winiszewski, MD
Phone	03 81 66 81 27
Email	hwiniszewski@chu-besancon.fr
Status	Recruiting
Phase	Phase 3
Start date	January 9, 2022
Completion date	July 9, 2024

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation in Patients Supported by Veino-arterial ECMO for Cardiogenic Shock — ECMOxy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms