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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Targeted PO2 postoxygenator is obtained by modulating ECMO Membrane oxygen fraction.
CHU de Besançon
Besançon, France
Enterocyte damage
Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration
Time frame: At day 2
Feasibility of the oxygenation protocol
Percentage of time in the oxygenation target
Time frame: From day 0 to day 6
Security of the oxygenation protocol
Number of right radial PaO2 below 80 mmHg
Time frame: From day 0 to day 6
Organ failure
Death or severe stroke (NIHSS \> 11) or mesenteric ischemia
Time frame: From day 0 to day 30
Organ failure
Non cardiac component of the Sequential Organ Failure Assessment (SOFA) score
Time frame: At day 0, day 2 and day 6
Organ failure
Plasma lactate concentration
Time frame: At day 0, day 2 and day 6
Enterocyte damage
Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration
Time frame: At day 0, and day 1
Enterocyte function
Difference between plasma citrulline concentrations at day 0 and day 2
Time frame: At day 0 and day 2
Liver failure
Plasma Aspartate aminotransferase (ASAT) concentration
Time frame: At day 0, day 2 and day 6
Liver failure
Prothrombine time
Time frame: At day 0, day 2 and day 6
Renal failure
Plasma creatinine concentration
Time frame: At day 0, day 2 and day 6
Renal failure
Need for renal replacement therapy
Time frame: From 0 to day 6
Systemic inflammation
Plasma CRP, TNF alpha, IL6 and IL8 concentrations
Time frame: At day 0, day 2 and day 6
Anti-oxydant stock
Plasma vitamin C, vitamin E, and Glutathion concentrations
Time frame: At day 0, day 2 and day 6
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