Post-Surgery Extracorporeal Life Support

Recruiting

• Conditions: Post Cardiac Arrest Syndrome; Cardiogenic Shock; Post-cardiac Surgery; Extracorporeal Membrane Oxygenation Complication; Extracorporeal Life Support

• Registration Number: NCT04330651
• Lead Sponsor: University of Florence

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-31
• Study First Posted: 2020-04-01
• Primary Completion: 2021-03-19
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28
• Study Completion: 2029-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients underwent cardiac surgery

Exclusion Criteria

• Age < 18 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	At 5 years after surgery	late survival

Secondary Outcome Measures

Name	Time	Method
Prognostic Factors	Late: 5 years after surgery	Identify early and late negative and positive prognostic factors
Prognostic factors	Early: 1 month after surgery	Identify early and late negative and positive prognostic factors

Trial Locations

Locations (1)

Massimo Bonacchi; 🇮🇹 Florence, Italy