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Post-Surgery Extracorporeal Life Support

NCT ID: NCT04330651

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2029-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiogenic Shock Extracorporeal Life Support Extracorporeal Membrane Oxygenation Complication Post Cardiac Arrest Syndrome Post-cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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ECLS

Emergency application of Extracorporeal Life Support in post-surgical patients

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients underwent cardiac surgery

Exclusion Criteria

* Age \< 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sandro Gelsomino

UNKNOWN

Sponsor Role collaborator

Edvin Prifti

UNKNOWN

Sponsor Role collaborator

Francesco Cabrucci

UNKNOWN

Sponsor Role collaborator

Marco Bugetti

UNKNOWN

Sponsor Role collaborator

Orlando Parise

UNKNOWN

Sponsor Role collaborator

Aleksander Dokollari

UNKNOWN

Sponsor Role collaborator

University of Florence

OTHER

Sponsor Role lead

Responsible Party

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Massimo Bonacchi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massimo Bonacchi

Florence, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Massimo Bonacchi, MD

Role: primary

[email protected]
393389855782

Other Identifiers

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PC-ECLS Study

Identifier Type: -

Identifier Source: org_study_id

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