Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation in Patients Supported by Veino-arterial ECMO for Cardiogenic Shock
- Conditions
- Extracorporeal Membrane OxygenationCardiogenic Shock
- Interventions
- Registration Number
- NCT04990349
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Patient supported by veino-arterial ECMO for cardiogenic shock for less than 6 hours
- Affiliation to social protection
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Extracorporeal hyperoxemia Oxygen gas * 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. Extracorporeal normoxemia Oxygen gas * 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.
- Primary Outcome Measures
Name Time Method Enterocyte damage At day 2 Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration
- Secondary Outcome Measures
Name Time Method Enterocyte damage At day 0, and day 1 Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration
Liver failure At day 0, day 2 and day 6 Prothrombine time
Renal failure From 0 to day 6 Need for renal replacement therapy
Security of the oxygenation protocol From day 0 to day 6 Number of right radial PaO2 below 80 mmHg
Feasibility of the oxygenation protocol From day 0 to day 6 Percentage of time in the oxygenation target
Organ failure At day 0, day 2 and day 6 Plasma lactate concentration
Enterocyte function At day 0 and day 2 Difference between plasma citrulline concentrations at day 0 and day 2
Systemic inflammation At day 0, day 2 and day 6 Plasma CRP, TNF alpha, IL6 and IL8 concentrations
Anti-oxydant stock At day 0, day 2 and day 6 Plasma vitamin C, vitamin E, and Glutathion concentrations
Trial Locations
- Locations (1)
CHU de Besançon
🇫🇷Besancon, France