To vent or not on veno-arterial extracorporeal membrane oxygenation, does it improve myocardial recovery and outcome?
Daniele Camboni, Christof Schmid
https://pubmed.ncbi.nlm.nih.gov/29312691Actively Recruiting
Age: 1Day - 80Years
All Genders
ID06766006
A Multicentric Left Ventricular Venting Strategy Comparison in Patients Receiving Venoarterial Extracorporeal Life Support
Led by Maastricht University Medical Center · Updated on 2025-01-09
500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Maastricht University Medical Center
Lead Sponsor
I
IRCCS Policlinico S. Donato
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to collect and analyze clinical data from patients receiving veno-arterial extracorporeal life support (VA ECLS) in intensive care units worldwide. It focuses on understanding left ventricular (LV) overload and comparing different methods to unload the LV during VA ECLS. The study addresses the serious conditions of cardiogenic shock and cardiac arrest, which have high mortality rates, and aims to clarify the best strategies for LV unloading to support heart function recovery. The study observes patients who have undergone implantation of VA ECLS, a procedure that supports heart and lung function by circulating blood outside the body. Researchers will document and compare various LV unloading techniques used in standard care across multiple centers, without adding extra interventions. Data on timing, types, and methods of unloading will be collected, along with clinical and radiological information before and after unloading. Participants' demographic, clinical, instrumental, and laboratory data will be gathered before and after VA ECLS implantation. Researchers will assess outcomes such as in-hospital mortality at 30 days, echocardiographic measures of LV overload and unloading effectiveness, major adverse events, LV function, and neurological status at discharge. The study is prospective and observational, with no additional treatments beyond usual care, and will follow patients up to 30 days after the procedure.
CONDITIONS
Brief Title
ECMO LEft Ventricle UNloading Strategy
Who Can Participate
Age: 1Day - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- All patients undergoing VA ECLS will be enrolled.
You will not qualify if you...
- Patients without VA ECMO will not be considered
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Duration of VA ECLS support as per clinical need
Participants undergo implantation of venoarterial extracorporeal life support (VA ECLS) as part of routine care for refractory cardiogenic shock or cardiac arrest.
Data collected before and after VA ECLS implantation according to standard care
Long-term Monitoring
Duration - Up to 30 days after implantation
Participants are observed to assess left ventricular unloading strategies, clinical outcomes, and recovery during and after VA ECLS treatment.
Assessments within 12 hours before and 12 hours after unloading technique and follow-up at Day 30
Trial Site Locations
Total: 1 location
1
Maastricht UMC
Maastricht, Netherlands
Actively Recruiting
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Research Team
P
Paolo Meani, MD, PhD
R
Roberto Lorusso, MD,PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Left Ventricular Unloading Is Associated With Lower Mortality in Patients With Cardiogenic Shock Treated With Venoarterial Extracorporeal Membrane Oxygenation: Results From an International, Multicenter Cohort Study.
Benedikt Schrage, Peter Moritz Becher, Alexander Bernhardt...
https://pubmed.ncbi.nlm.nih.gov/33032450A 5-year experience with cardiopulmonary resuscitation using extracorporeal life support in non-postcardiotomy patients with cardiac arrest.
Assad Haneya, Alois Philipp, Claudius Diez...
https://pubmed.ncbi.nlm.nih.gov/22819880Early experiences with miniaturized extracorporeal life-support in the catheterization laboratory.
Matthias Arlt, Alois Philipp, Sabine Voelkel...
https://pubmed.ncbi.nlm.nih.gov/22555310Left ventricular unloading during veno-arterial ECMO: a review of percutaneous and surgical unloading interventions.
Dirk W Donker, Daniel Brodie, José P S Henriques...
https://pubmed.ncbi.nlm.nih.gov/30112975ECPella: Concept, Physiology and Clinical Applications.
P Meani, R Lorusso, F Pappalardo
https://pubmed.ncbi.nlm.nih.gov/33642170Modalities and Effects of Left Ventricle Unloading on Extracorporeal Life support: a Review of the Current Literature.
Paolo Meani, Sandro Gelsomino, Eshan Natour...
https://pubmed.ncbi.nlm.nih.gov/28470925Protracted aortic valve closure during peripheral veno-arterial extracorporeal life support: is intra-aortic balloon pump an effective solution?
Paolo Meani, Thijs Delnoij, Giuseppe M Raffa...
https://pubmed.ncbi.nlm.nih.gov/30024298Simultaneous Venoarterial Extracorporeal Membrane Oxygenation and Percutaneous Left Ventricular Decompression Therapy with Impella Is Associated with Improved Outcomes in Refractory Cardiogenic Shock.
Sandeep M Patel, Jerry Lipinski, Sadeer G Al-Kindi...
https://pubmed.ncbi.nlm.nih.gov/29489461Mechanical Left Ventricular Unloading in Patients Undergoing Venoarterial Extracorporeal Membrane Oxygenation.
E Wilson Grandin, Jose I Nunez, Brooks Willar...
https://pubmed.ncbi.nlm.nih.gov/35361346