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Recruiting NCT04330651

NCT04330651 Post-Surgery Extracorporeal Life Support

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Clinical Trial Summary
NCT ID NCT04330651
Status Recruiting
Phase —
Sponsor University of Florence
Condition Cardiogenic Shock
Study Type OBSERVATIONAL
Enrollment 500 participants
Start Date 2004-01
Primary Completion 2021-03-19

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 80 Years
Study Type OBSERVATIONAL
Interventions
ECLS

Eligibility Fast-Check

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 500 participants in total. It began in 2004-01 with a primary completion date of 2021-03-19.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

Eligibility Criteria

Inclusion Criteria: * Patients underwent cardiac surgery Exclusion Criteria: * Age \< 18 years

Frequently Asked Questions

Who can join the NCT04330651 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT04330651 currently recruiting?

Yes, NCT04330651 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Florence to inquire about joining.

Where is the NCT04330651 trial being conducted?

This trial is being conducted at Florence, Italy.

Who is sponsoring the NCT04330651 clinical trial?

NCT04330651 is sponsored by University of Florence. The trial plans to enroll 500 participants.

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