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

NCT06250439 | Completed

• 1 other identifier: APHP231770
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cardiogenic shock; Pulmonary arterial occlusion pressure; PAOP; VA ECMO; Left ventricle unloading

Outcome Measures

Primary Outcomes (1)

• PAPO variation

  Measurement of the variation in occluded pulmonary arterial pressure (PAOP in mmHg) using the pulmonary arterial catheter during different stages of peripheral VA-ECMO flow variation. The variation in PAOP (ΔPAOP) is the calculated difference between the PAOP measured at the end of the protocol (PAOP200%) and that measured at the beginning of the protocol (PAOP100%), estimated as a percentage according to the following formula: ΔPAOP(%) = (PAOP200% - PAOP100%) / PAOP200% × 100 In accordance with literature, a 20% variation in PAOP between the two flow rates will be considered significant.

  during 1 day after inclusion

Study Arms (1)

Adult patients with peripheral VA-ECMO for refractory cardiogenic shock

EXPERIMENTAL

Adult patients with peripheral VA-ECMO for refractory cardiogenic shock, hospitalized in medical ICU of Pitié Salpêtrière Hospital, AP-HP Paris

Other: ECMO-Flow variations

Interventions

ECMO-Flow variations OTHER

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.

Adult patients with peripheral VA-ECMO for refractory cardiogenic shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 affiliated with or entitled to a social security scheme (excluding State Medical Assistance)

You may not qualify if:

• Patient unable to tolerate variations in VA-ECMO flow due to ongoing major hemodynamic instability.
• Patient under legal protection measures.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de réanimation médicale, Hôpital Pitié-Salpêtrière,

Paris, 75013, France

Location

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 9, 2024
• Study Start: March 7, 2024
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)