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

NCT04990349 | Completed Phase 3

• 1 other identifier: ECMOxy - pilot study
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiogenic Shock; Extracorporeal Membrane Oxygenation

Keywords

Cardiogenic shock; Extracorporeal Membrane Oxygenation; Hyperoxia

Outcome Measures

Primary Outcomes (1)

• Enterocyte damage

  Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration

  At day 2

Secondary Outcomes (13)

• Feasibility of the oxygenation protocol

  From day 0 to day 6

• Security of the oxygenation protocol

  From day 0 to day 6

• Organ failure

  From day 0 to day 30

• Organ failure

  At day 0, day 2 and day 6

• Organ failure

  At day 0, day 2 and day 6

Study Arms (2)

Extracorporeal normoxemia

EXPERIMENTAL

* 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.

Drug: Oxygen gas

Extracorporeal hyperoxemia

ACTIVE COMPARATOR

* 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.

Drug: Oxygen gas

Interventions

Oxygen gas DRUG

Targeted PO2 postoxygenator is obtained by modulating ECMO Membrane oxygen fraction.

Extracorporeal hyperoxemia; Extracorporeal normoxemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient supported by veino-arterial ECMO for cardiogenic shock for less than 6 hours
• Affiliation to social protection

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

CHU de Besançon

Besançon, France

Location

Related Publications (4)

• 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.

  PMID: 28787294 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.

  PMID: 23322670 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.

  PMID: 28506763 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.

  PMID: 30966908 RESULT

MeSH Terms

Conditions

Shock, Cardiogenic; Hyperoxia

Interventions

nitrox

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two arms

Study Record Dates

• First Submitted: July 30, 2021
• First Posted: August 4, 2021
• Study Start: January 9, 2022
• Primary Completion: November 10, 2023
• Study Completion: December 1, 2023
• Last Updated: December 30, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 2023

Locations

FR (1)