MedTrace Logo

Effect of Peripheral VA-ECMO Flow Variations on the Pulmonary Arterial Occlusion Pressure (PAPO) in Patients With Refractory Cardiogenic Shock.

NCT06250439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-04-13

No results posted yet for this study

Summary

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.

Conditions

  • Cardiogenic Shock

Interventions

OTHER

ECMO-Flow variations

The protocol unfolds in 5 steps as follows, each step lasting between 10 and 15 minutes to allow for the patient's hemodynamic adaptation. At each step, invasive and non-invasive hemodynamic evaluation is performed. 1. The 1st step is called "100% flow": it involves recording the patient's hemodynamic measurements at the baseline, i.e., at 100% of their ECMO-VA flow, previously set by the clinician entirely independently of the study. 2. The 2nd step is called "125% flow": the patient's ECMO-VA flow is increased to 125% of the initial flow. 3. The 3rd step is called "150% flow": the patient's ECMO-VA flow is increased to 150% of the initial flow. 4. The 4th step is called "175% flow": the patient's ECMO-VA flow is increased to 175% of the initial flow. 5. The 5th and final step is called "200% flow": the patient's ECMO-VA flow is increased to 200% of the initial flow.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2025-01-13
Completion
2025-01-13

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250439 on ClinicalTrials.gov