Cardiogenic ShockPhase 3ECMOxyNCT04990349
Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation in Patients Supported by Veino-arterial ECMO for Cardiogenic Shock
A Phase 3 study testing Oxygen gas in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Extracorporeal Membrane Oxygenation
- What is being tested?
- Oxygen gas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2022to 1 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient supported by veino-arterial ECMO for cardiogenic shock for less than 6 hours
- Affiliation to social protection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation : Impact on Organ Dysfunction 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.
Read the 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.
- Being tested
- Oxygen gas
- Keywords
- Cardiogenic shock, Extracorporeal Membrane Oxygenation, Hyperoxia
- Medical subject headings
- Shock, Cardiogenic, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen gasDrug
Targeted PO2 postoxygenator is obtained by modulating ECMO Membrane oxygen fraction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oxygen gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enterocyte damage
Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration
Measured: At day 2
Secondary outcomes (13)
Feasibility of the oxygenation protocol
Percentage of time in the oxygenation target
Measured: From day 0 to day 6
Security of the oxygenation protocol
Number of right radial PaO2 below 80 mmHg
Measured: From day 0 to day 6
Organ failure
Death or severe stroke (NIHSS > 11) or mesenteric ischemia
Measured: From day 0 to day 30
Organ failure
Non cardiac component of the Sequential Organ Failure Assessment (SOFA) score
Measured: At day 0, day 2 and day 6
Organ failure
Plasma lactate concentration
Measured: At day 0, day 2 and day 6
Enterocyte damage
Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration
Measured: At day 0, and day 1
Enterocyte function
Difference between plasma citrulline concentrations at day 0 and day 2
Measured: At day 0 and day 2
Liver failure
Plasma Aspartate aminotransferase (ASAT) concentration
Measured: At day 0, day 2 and day 6
Liver failure
Prothrombine time
Measured: At day 0, day 2 and day 6
Renal failure
Plasma creatinine concentration
Measured: At day 0, day 2 and day 6
Renal failure
Need for renal replacement therapy
Measured: From 0 to day 6
Systemic inflammation
Plasma CRP, TNF alpha, IL6 and IL8 concentrations
Measured: At day 0, day 2 and day 6
Anti-oxydant stock
Plasma vitamin C, vitamin E, and Glutathion concentrations
Measured: At day 0, day 2 and day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start9 Jan 2022
- Primary completion10 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two arms
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990349
- Sponsor's protocol ID
- ECMOxy - pilot study
- Acronym
- ECMOxy
- Status last verified
- Sep 2023
- First submitted
- 30 Jul 2021
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 28787294Hayes 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.
PubMed 23322670Chou 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.
PubMed 28506763Falk 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.
PubMed 30966908
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation : Impact on Organ Dysfunction in Patients Supported by Veino-arterial ECMO for Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT04990349
- Acronym / sponsor ID
- ECMOxy / ECMOxy - pilot study
- Keywords
- Cardiogenic shock, Extracorporeal Membrane Oxygenation, Hyperoxia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 9 Jan 2022 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two arms
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal normoxemia | Experimental | Drug: Oxygen gas* 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. |
| Extracorporeal hyperoxemia | Active comparator | Drug: Oxygen gas* 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient supported by veino-arterial ECMO for cardiogenic shock for less than 6 hours
- Affiliation to social protection
Key exclusion criteria (8 listed)
- Age < 18 years old
- Pregnancy
- Opposition of the patient or his relatives
- Cannulation during cardiopulmonary resuscitation
- Cardiopulmonary resuscitation duration > 10 minutes before ECMO implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen gasTargeted PO2 postoxygenator is obtained by modulating ECMO Membrane oxygen fraction. | Drug | Extracorporeal hyperoxemia, Extracorporeal normoxemia |
Primary outcome
Enterocyte damage
Time frame: At day 2
Plasma Intestinal Fatty Acid Biding Protein (I-FABP) concentration
13 secondary outcomes
Feasibility of the oxygenation protocol
Time frame: From day 0 to day 6
Security of the oxygenation protocol
Time frame: From day 0 to day 6
Organ failure
Time frame: From day 0 to day 30
Organ failure
Time frame: At day 0, day 2 and day 6
Organ failure
Time frame: At day 0, day 2 and day 6
Enterocyte damage
Time frame: At day 0, and day 1
Enterocyte function
Time frame: At day 0 and day 2
Liver failure
Time frame: At day 0, day 2 and day 6
Liver failure
Time frame: At day 0, day 2 and day 6
Renal failure
Time frame: At day 0, day 2 and day 6
Renal failure
Time frame: From 0 to day 6
Systemic inflammation
Time frame: At day 0, day 2 and day 6
Anti-oxydant stock
Time frame: At day 0, day 2 and day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Results publication: PubMed 28787294Munshi 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.
- Results publication: PubMed 23322670Hayes 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.
- Results publication: PubMed 28506763Chou 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.
- Results publication: PubMed 30966908Falk 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxygen gas in people with Cardiogenic Shock and Extracorporeal Membrane Oxygenation, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enterocyte damage (time frame: At day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04990349, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.