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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04990349
Collaborator
(none)
60
Enrollment
2
Arms
14
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oxygen gas
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trial with two armsRandomized controlled trial with two arms
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation : Impact on Organ Dysfunction in Patients Supported by Veino-arterial ECMO for Cardiogenic Shock
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Extracorporeal normoxemia

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
Targeted PO2 postoxygenator is obtained by modulating ECMO Membrane oxygen fraction.
Active Comparator: Extracorporeal hyperoxemia

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

Outcome Measures

Primary Outcome Measures

  1. Enterocyte damage [At day 2]

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

Secondary Outcome Measures

  1. Feasibility of the oxygenation protocol [From day 0 to day 6]

    Percentage of time in the oxygenation target

  2. Security of the oxygenation protocol [From day 0 to day 6]

    Number of right radial PaO2 below 80 mmHg

  3. Organ failure [From day 0 to day 30]

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

  4. Organ failure [At day 0, day 2 and day 6]

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

  5. Organ failure [At day 0, day 2 and day 6]

    Plasma lactate concentration

  6. Enterocyte damage [At day 0, and day 1]

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

  7. Enterocyte function [At day 0 and day 2]

    Difference between plasma citrulline concentrations at day 0 and day 2

  8. Liver failure [At day 0, day 2 and day 6]

    Plasma Aspartate aminotransferase (ASAT) concentration

  9. Liver failure [At day 0, day 2 and day 6]

    Prothrombine time

  10. Renal failure [At day 0, day 2 and day 6]

    Plasma creatinine concentration

  11. Renal failure [From 0 to day 6]

    Need for renal replacement therapy

  12. Systemic inflammation [At day 0, day 2 and day 6]

    Plasma CRP, TNF alpha, IL6 and IL8 concentrations

  13. Anti-oxydant stock [At day 0, day 2 and day 6]

    Plasma vitamin C, vitamin E, and Glutathion concentrations

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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 ans

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT04990349
Other Study ID Numbers:
  • ECMOxy - pilot study
First Posted:
Aug 4, 2021
Last Update Posted:
Aug 4, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Besancon
Cardiogenic shock
Extracorporeal Membrane Oxygenation
Hyperoxia
Additional relevant MeSH terms:
Shock, Cardiogenic
Shock

Study Results

No Results Posted as of Aug 4, 2021