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Effects of Levosimendan in patients being weaned from venoarterial extracorporal membrane oxygenation. A randomized controlled investigator driven phase II trial
EU CTIS ID: 2023-508024-36-00
What this study is testing
The objective of this trial is to assess the efficacy of Levosimendan in improving indices of cardiac output and pulsatile flow, thus facilitating weaning from ECMO. Primary outcome: Change in left ventricular outflow tract velocity time integral measured by Doppler echocardiography from baseline to 72h after initiation ECMO or before cessation of ECMO support, whichever occurs first
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Age ≥ 18 years; • Undergoing ECMO for cardiogenic shock or refractory cardiac arrest
You likely can't join if
- • Coma with fixed dilatation of pupils that was not induced by drugs or other circumstances indicating likely futility • Mechanical cause of cardiogenic shock (e.g., ventricular septal defect or papillary muscle rupture) • Onset of shock more than 12 hours before screening • Massive pulmonary embolism • Severe peripheral arterial disease precluding insertion of ECMO cannula • Aortic regurgitation greater than grade II in severity (on a scale of I to IV, with higher grades indicating more severe regurgitation) • Age > 90 years • Severe concomitant disease associated with a life expectancy of less than 6 months • Pregnant women
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.