Trials / Completed
CompletedNCT06046339
Left Ventricular Ejection Fraction in Cardiac Arrest Survivors Treated With Extracorporeal Cardiopulmonary Resuscitation
Evolution of Left Ventricular Ejection Fraction After Treatment of Out-of-hospital Cardiac Arrest by Extracorporeal Cardiopulmonary Resuscitation
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 116 (actual)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
Extra-hospital cardiac arrest is a major public health problem, with approximately 46,000 cases per year. Nearly 71% of the patients for whom resuscitation was initiated did not present a return of spontaneous circulation on scene and only 29% were transported alive to the hospital. In this context, extracorporeal cardiopulmonary resuscitation (ECPR) by veno-arterial extracorporeal membrane oxygenation has been developed as a second line of treatment according to the latest international guidelines. The selection of eligible patients as well as the timing of initiation of ECPR has long been controversial, but expert recommendations have recently been published. After an out-of-hospital cardiac arrest of cardiological cause, an early ventricular dysfunction has been previously described, more particularly in hemodynamically unstable patients. This dysfunction was associated with greater early in-hospital mortality. There are few data on the medium-term course of left ventricular dysfunction and the largest study addressing this question showed that the severity of left ventricular involvement was associated with greater long-term morbidity and mortality. However, it also found that left ventricular ejection fraction was partially reversible in 29% of the study population. It seems so far, the medium-term evolution of left heart dysfunction had not been described in the context of refractory extra-hospital cardiac arrest treated by ECPR. However, these patients are particularly severe, hemodynamically unstable and potentially at risk of developing long-term sequelae.
Detailed description
Extra-hospital cardiac arrest is a major public health problem, with approximately 46,000 cases per year. Nearly 71% of the patients for whom resuscitation was initiated did not present a return of spontaneous circulation on scene and only 29% were transported alive to the hospital. In this context, extracorporeal cardiopulmonary resuscitation (ECPR) by veno-arterial extracorporeal membrane oxygenation has been developed as a second line of treatment according to the latest international guidelines. The selection of eligible patients as well as the timing of initiation of ECPR has long been controversial, but expert recommendations have recently been published. After an out-of-hospital cardiac arrest of cardiological cause, an early ventricular dysfunction has been previously described, more particularly in hemodynamically unstable patients. This dysfunction was associated with greater early in-hospital mortality. There are few data on the medium-term course of left ventricular dysfunction and the largest study addressing this question showed that the severity of left ventricular involvement was associated with greater long-term morbidity and mortality. However, it also found that left ventricular ejection fraction was partially reversible in 29% of the study population. It seems so far, the medium-term evolution of left heart dysfunction had not been described in the context of refractory extra-hospital cardiac arrest treated by ECPR. However, these patients are particularly severe, hemodynamically unstable and potentially at risk of developing long-term sequelae. The research focuses on the evolution of left ventricular function at 28 and 90 days after an out-of-hospital refractory cardiac arrest treated with ECPR as well as describing the survival rate at 28 and 90 days for these patients. The expected results are to demonstrate that the left ventricular function, described through the left ventricular ejection fraction, is seriously affected in the population studied without signs of reversibility. These patients would therefore need close cardiological follow-up and to be integrated into a dedicated care pathway.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Collection of data from the patient's medical file | Collection of data from the patient's medical file. |
Timeline
- Start date
- 2024-04-24
- Primary completion
- 2024-05-04
- Completion
- 2024-05-04
- First posted
- 2023-09-21
- Last updated
- 2025-09-12
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT06046339. Inclusion in this directory is not an endorsement.