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Post-Surgery Extracorporeal Life Support

Study acronym: PC-ECLS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Mar 19, 2020 to Mar 19, 2021v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Extracorporeal Life Support (ECLS) may provide pulmonary and circulatory support for patients with acute heart failure refractory to conventional medical therapy. However, indications and effectiveness of ECLS engagement post-surgery remains a concern. The investigators sought to analyze indications, modality and outcomes of PS-ECLS, to identify predictors of early and midterm survival after PS-ECLS. The investigators have recorded prospectively, and analysed data of 209 consecutive PS-ECLS patients between January 2004 and December 2018. Demographic and clinical data before, during and after PS-ECLS were collected and their influence on hospital mortality and outcomes (early and midterm) will analyse. Multivariate analysis of pre PS-ECLS implantation factors (as age, female sex , insulin-dependent diabetes, pulmonary hypertension, STS, type of surgical procedure data, pre-ECLS blood lactate level) will be made for identify prognostic risk factors of in-hospital mortality. Overall survival will be analysed, at 6 months,1-year and 5-years, respectively and the factors influencing mild/term outcome will be investigated.
Trial Details
NCT Number NCT04330651
Lead Sponsor University of Florence
Collaborators: Sandro Gelsomino, Edvin Prifti, Francesco Cabrucci, Marco Bugetti, Orlando Parise, Aleksander Dokollari
Conditions
(from sponsor)		 Cardiogenic Shock, Extracorporeal Life Support, Extracorporeal Membrane Oxygenation Complication, Post Cardiac Arrest Syndrome, Post-cardiac Surgery
Related terms Post-Cardiac Arrest Syndrome, Shock, Cardiogenic
Enrollment 500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov