NCT06250439Befejeződött
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. ápr. 13.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 80 (tényleges)
- Első benyújtás
- 2024. jan. 15.
- Kezdés
- 2024. márc. 7.
- Elsődleges befejezés
- 2025. jan. 13.
- Fő szponzor
- Assistance Publique - Hôpitaux de Paris
- NCT-szám
- NCT06250439
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 80
- 2024. márc. 7. és az elsődleges befejezés (2025. jan. 13.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Egyéb
- 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.
Kiket keres a vizsgálat
- 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)
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Service de réanimation médicale, Hôpital Pitié-Salpêtrière, | Paris | Franciaország | Ismeretlen állapot |
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