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NCT Number: NCT04990349

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

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.

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Key information

Conditions

Cardiogenic Shock Cardiovascular Diseases Extracorporeal Membrane Oxygenation Heart Diseases Hyperoxia Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Signs and Symptoms Signs and Symptoms, Respiratory Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU de Besançon

Besançon, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxygen gas

Drug

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

Primary outcomes

  1. Enterocyte damage

    Time frame: At day 2

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

Secondary outcomes

  1. Feasibility of the oxygenation protocol

    Time frame: From day 0 to day 6

    Percentage of time in the oxygenation target

  2. Security of the oxygenation protocol

    Time frame: From day 0 to day 6

    Number of right radial PaO2 below 80 mmHg

  3. Organ failure

    Time frame: From day 0 to day 30

    Death or severe stroke (NIHSS > 11) or mesenteric ischemia

  4. Organ failure

    Time frame: At day 0, day 2 and day 6

    Non cardiac component of the Sequential Organ Failure Assessment (SOFA) score

  5. Organ failure

    Time frame: At day 0, day 2 and day 6

    Plasma lactate concentration

  6. Enterocyte damage

    Time frame: At day 0, and day 1

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

  7. Enterocyte function

    Time frame: At day 0 and day 2

    Difference between plasma citrulline concentrations at day 0 and day 2

  8. Liver failure

    Time frame: At day 0, day 2 and day 6

    Plasma Aspartate aminotransferase (ASAT) concentration

  9. Liver failure

    Time frame: At day 0, day 2 and day 6

    Prothrombine time

  10. Renal failure

    Time frame: At day 0, day 2 and day 6

    Plasma creatinine concentration

  11. Renal failure

    Time frame: From 0 to day 6

    Need for renal replacement therapy

  12. Systemic inflammation

    Time frame: At day 0, day 2 and day 6

    Plasma CRP, TNF alpha, IL6 and IL8 concentrations

  13. Anti-oxydant stock

    Time frame: At day 0, day 2 and day 6

    Plasma vitamin C, vitamin E, and Glutathion concentrations

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Official study title

Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation : Impact on Organ Dysfunction in Patients Supported by Veino-arterial ECMO for Cardiogenic Shock

Acronym: ECMOxy

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2021
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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