NCT06250439Completed
Effect of Peripheral VA-ECMO Flow Variations on the Pulmonary Arterial Occlusion Pressure (PAPO) in Patients With Refractory Cardiogenic Shock.
Effect of Peripheral VA-ECMO Flow Variations on the Pulmonary Arterial Occlusion Pressure (PAPO) in Patients With Refractory Cardiogenic Shock: the PAPO-Flow Study
Source: ClinicalTrials.gov · Last updated 13 Apr 2025
Brief summary (registry, in English)
This study focuses on a population of adult patients placed under peripheral Veno-Arterial Extracorporeal Membrane Oxygenation (VA-ECMO) for refractory cardiogenic shock. Cardiogenic shock, primarily caused by myocardial infarction, is associated with a high mortality rate that remains around 50%, despite advancements in the field of coronary reperfusion. VA-ECMO is a rapidly growing cardiac support technique worldwide. Its goal is to improve peripheral organ perfusion even as myocardial damage continues, thereby enhancing the prognosis of patients with severe multiorgan failure. VA-ECMO is a temporary cardio-respiratory support technique based on the principle of extracorporeal circulation. However, patients under VA-ECMO are at risk of experiencing various complications, including infectious, thromboembolic, hemorrhagic complications, or malfunctions of the ECMO machine itself, with the incidence increasing with the duration of assistance. Numerous authors and scientific reviews highlight the increased risk of Acute Pulmonary Edema (APE) in patients under peripheral VA-ECMO, attributing it to the elevation of afterload induced by retrograde arterial reinfusion against the residual native blood flow, hypothetically leading to an increase in Pulmonary Artery Occlusion Pressure (PAOP). This phenomenon is presumed to intensify as the VA-ECMO reinfusion rate increases. Furthermore, APE under ECMO-VA represents a turning point in the patient's course. Brechot et al. demonstrated that patients who developed APE under VA-ECMO had a prolonged ECMO duration, a higher reliance on mechanical ventilation, an extended stay in critical care, and a higher mortality rate compared to patients who had previously undergone a left ventricular unloading technique (aimed at reducing PAOP and the risk of APE). However, until now, no physiological study has assessed the specific effect of the variation in peripheral VA-ECMO flow on the change in PAOP during a dedicated protocol. It is with the aim of addressing this question that the investigators are considering the PAPO-Flow study.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 15 Jan 2024
- Start date
- 7 Mar 2024
- Primary completion date
- 13 Jan 2025
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- NCT number
- NCT06250439
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 7 Mar 2024 to the primary completion date, 13 Jan 2025
- 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
- SAPS-II Score \> 90 (Simplified Acute Physiology Score (SAPS-II)) at inclusion (calculated as part of the care).
- Patient unable to tolerate variations in VA-ECMO flow due to ongoing major hemodynamic instability.
- Patient under legal protection measures.
Who the study is looking for
- Major patient hospitalized in the medical intensive care unit at Pitié-Salpêtrière Hospital, under peripheral VA-ECMO for refractory cardiogenic shock and already equipped with a previously placed pulmonary arterial catheter before the study.
- The patient must be deemed "stabilized under ECMO" by one of the study investigators so that variations in VA-ECMO flow can be tolerated.
- Patient aged 18 years or older.
- Patient hospitalized in the medical intensive care unit at Pitié-Salpêtrière Hospital.
- Patient on peripheral veno-arterial ECMO (Extracorporeal membrane oxygenation).
- Patient already equipped with a Swan-Ganz pulmonary arterial catheter and a radial arterial catheter (right or left) installed as part of the care.
- Patient judged stabilized under ECMO by the study investigators to tolerate variations in VA-ECMO flow (stabilization of catecholamine levels in the preceding hours, absence of severe pulmonary function impairment, no need for a transfusion of blood products within the following 2 hours).
- Patient or patient's representative (if the patient is not able to express themselves), having received informed information about the study, and whose written and voluntary consent has been obtained. Emergency inclusion will be possible in case the patient and their representative are unable to be informed and/or provide consent for the patient's inclusion.
- Patient affiliated with or entitled to a social security scheme (excluding State Medical Assistance)
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 |
|---|---|---|---|
| Service de réanimation médicale, Hôpital Pitié-Salpêtrière, Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.