Post-Surgery Extracorporeal Life Support (PC-ECLS)

April 27, 2021 updated by: Massimo Bonacchi, University of Florence

Outcomes' Predictors in Post-Surgery Extracorporeal Life Support

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Florence, Italy, 50144
        • Recruiting
        • Massimo Bonacchi
        • Contact:
        • Sub-Investigator:
          • Sandro Gelsomino, MD
        • Sub-Investigator:
          • Edvin Prifti, MD
        • Sub-Investigator:
          • Aleksander Dokollari, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients underwent cardiac surgery

Description

Inclusion Criteria:

  • Patients underwent cardiac surgery

Exclusion Criteria:

  • Age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 1 month after surgery
Evaluate Early, mid and late Survival
1 month after surgery
Survival
Time Frame: At 1 Year after surgery
mid-time survival
At 1 Year after surgery
Survival
Time Frame: At 5 years after surgery
late survival
At 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic factors
Time Frame: Early: 1 month after surgery
Identify early and late negative and positive prognostic factors
Early: 1 month after surgery
Prognostic Factors
Time Frame: Late: 5 years after surgery
Identify early and late negative and positive prognostic factors
Late: 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Collaborators

Sandro Gelsomino
Edvin Prifti
Francesco Cabrucci
Marco Bugetti
Orlando Parise
Aleksander Dokollari

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

March 19, 2021

Study Completion (Anticipated)

January 31, 2029

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC-ECLS Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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