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NCT04330651 Clinical Trial

Post-Surgery Extracorporeal Life Support

Cardiogenic Shock Clinical Trial

— PC-ECLS  

Official title:
Outcomes' Predictors in Post-Surgery Extracorporeal Life Support

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04330651
Other study ID # PC-ECLS Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2004
Est. completion date January 31, 2029

Study information
Verified date April 2021
Source University of Florence
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date January 31, 2029
Est. primary completion date March 19, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Patients underwent cardiac surgery Exclusion Criteria: - Age < 18 years

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ECLS
Emergency application of Extracorporeal Life Support in post-surgical patients

Locations
Country Name City State
Italy Massimo Bonacchi Florence

Sponsors (7)
Lead Sponsor Collaborator
University of Florence Aleksander Dokollari, Edvin Prifti, Francesco Cabrucci, Marco Bugetti, Orlando Parise, Sandro Gelsomino

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival Evaluate Early, mid and late Survival 1 month after surgery
Primary Survival mid-time survival At 1 Year after surgery
Primary Survival late survival At 5 years after surgery
Secondary Prognostic factors Identify early and late negative and positive prognostic factors Early: 1 month after surgery
Secondary Prognostic Factors Identify early and late negative and positive prognostic factors Late: 5 years after surgery
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