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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):
Description of the control arm (Hyperoxemia group):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extracorporeal normoxemia | Experimental |
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| Extracorporeal hyperoxemia | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen gas | Drug | Targeted PO2 postoxygenator is obtained by modulating ECMO Membrane oxygen fraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enterocyte damage | Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration | At day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the oxygenation protocol | Percentage of time in the oxygenation target | From day 0 to day 6 |
| Security of the oxygenation protocol | Number of right radial PaO2 below 80 mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besançon | Besançon | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28787294 | Result | Munshi L, Kiss A, Cypel M, Keshavjee S, Ferguson ND, Fan E. Oxygen Thresholds and Mortality During Extracorporeal Life Support in Adult Patients. Crit Care Med. 2017 Dec;45(12):1997-2005. doi: 10.1097/CCM.0000000000002643. | |
| 23322670 | Result | Hayes RA, Shekar K, Fraser JF. Is hyperoxaemia helping or hurting patients during extracorporeal membrane oxygenation? Review of a complex problem. Perfusion. 2013 May;28(3):184-93. doi: 10.1177/0267659112473172. Epub 2013 Jan 15. |
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2023
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Randomized controlled trial with two arms
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| From day 0 to day 6 |
| Organ failure | Death or severe stroke (NIHSS > 11) or mesenteric ischemia | From day 0 to day 30 |
| Organ failure | Non cardiac component of the Sequential Organ Failure Assessment (SOFA) score | At day 0, day 2 and day 6 |
| Organ failure | Plasma lactate concentration | At day 0, day 2 and day 6 |
| Enterocyte damage | Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration | At day 0, and day 1 |
| Enterocyte function | Difference between plasma citrulline concentrations at day 0 and day 2 | At day 0 and day 2 |
| Liver failure | Plasma Aspartate aminotransferase (ASAT) concentration | At day 0, day 2 and day 6 |
| Liver failure | Prothrombine time | At day 0, day 2 and day 6 |
| Renal failure | Plasma creatinine concentration | At day 0, day 2 and day 6 |
| Renal failure | Need for renal replacement therapy | From 0 to day 6 |
| Systemic inflammation | Plasma CRP, TNF alpha, IL6 and IL8 concentrations | At day 0, day 2 and day 6 |
| Anti-oxydant stock | Plasma vitamin C, vitamin E, and Glutathion concentrations | At day 0, day 2 and day 6 |
| 28506763 | Result | Chou HC, Chen CM. Neonatal hyperoxia disrupts the intestinal barrier and impairs intestinal function in rats. Exp Mol Pathol. 2017 Jun;102(3):415-421. doi: 10.1016/j.yexmp.2017.05.006. Epub 2017 May 12. |
| 30966908 | Result | Falk L, Sallisalmi M, Lindholm JA, Lindfors M, Frenckner B, Broome M, Broman LM. Differential hypoxemia during venoarterial extracorporeal membrane oxygenation. Perfusion. 2019 Apr;34(1_suppl):22-29. doi: 10.1177/0267659119830513. |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| D018496 | Hyperoxia |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C041364 | nitrox |
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