NCT04990349CompletedPhase 3
Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation in Patients Supported by Veino-arterial ECMO for Cardiogenic Shock
Normoxemic Versus Hyperoxemic Extracorporeal Oxygenation : Impact on Organ Dysfunction in Patients Supported by Veino-arterial ECMO for Cardiogenic Shock
Source: ClinicalTrials.gov · Last updated 30 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 30 Jul 2021
- Start date
- 9 Jan 2022
- Primary completion date
- 10 Nov 2023
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- NCT number
- NCT04990349
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 60
- From 9 Jan 2022 to the primary completion date, 10 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chronic intestinal disease
Age
- Age \< 18 years old
Other
- 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
Who the study is looking for
- Patient supported by veino-arterial ECMO for cardiogenic shock for less than 6 hours
- Affiliation to social protection
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Besançon Coordinator of this site? Confirm its status | Besançon | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.