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Clinical Trials/NCT04330651
NCT04330651
Recruiting
Not Applicable

Outcomes' Predictors in Post-Surgery Extracorporeal Life Support

University of Florence1 site in 1 country500 target enrollmentJanuary 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiogenic Shock
Sponsor
University of Florence
Enrollment
500
Locations
1
Primary Endpoint
Survival
Status
Recruiting
Last Updated
5 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
January 31, 2029
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Massimo Bonacchi

Professor

University of Florence

Eligibility Criteria

Inclusion Criteria

  • Patients underwent cardiac surgery

Exclusion Criteria

  • Age \< 18 years

Outcomes

Primary Outcomes

Survival

Time Frame: At 5 years after surgery

late survival

Secondary Outcomes

  • Prognostic Factors(Late: 5 years after surgery)
  • Prognostic factors(Early: 1 month after surgery)

Study Sites (1)

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