Cardiogenic Shock, Extracorporeal Membrane Oxygenation
Conditions
Keywords
Cardiogenic shock, Extracorporeal Membrane Oxygenation, Hyperoxia
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.
Interventions
DRUGOxygen gas
Targeted PO2 postoxygenator is obtained by modulating ECMO Membrane oxygen fraction.
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial with two arms
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient supported by veino-arterial ECMO for cardiogenic shock for less than 6 hours * Affiliation to social protection
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enterocyte damage | At day 2 | Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the oxygenation protocol | From day 0 to day 6 | Percentage of time in the oxygenation target |
| Security of the oxygenation protocol | From day 0 to day 6 | Number of right radial PaO2 below 80 mmHg |
| Organ failure | From day 0 to day 30 | Death or severe stroke (NIHSS \> 11) or mesenteric ischemia |
| Enterocyte damage | At day 0, and day 1 | Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration |
| Anti-oxydant stock | At day 0, day 2 and day 6 | Plasma vitamin C, vitamin E, and Glutathion concentrations |
| Liver failure | At day 0, day 2 and day 6 | Plasma Aspartate aminotransferase (ASAT) concentration |
| Renal failure | At day 0, day 2 and day 6 | Plasma creatinine concentration |
| Systemic inflammation | At day 0, day 2 and day 6 | Plasma CRP, TNF alpha, IL6 and IL8 concentrations |
| Enterocyte function | At day 0 and day 2 | Difference between plasma citrulline concentrations at day 0 and day 2 |
Countries
France
Outcome results
None listed