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NCT Number: NCT04330651

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.

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Key information

Conditions

Cardiogenic Shock Brain Diseases Brain Injuries Cardiovascular Diseases Central Nervous System Diseases Extracorporeal Life Support Extracorporeal Membrane Oxygenation Complication Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Post Cardiac Arrest Syndrome Post-Cardiac Arrest Syndrome Post-cardiac Surgery Postoperative Complications Reperfusion Injury Shock Shock, Cardiogenic Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Massimo Bonacchi

Florence, 50144, Italy

Location status: Recruiting

Location contact

Aleksander Dokollari, MD

SUB_INVESTIGATOR

Edvin Prifti, MD

SUB_INVESTIGATOR

Massimo Bonacchi, MD

CONTACT

[email protected]

393389855782

Sandro Gelsomino, MD

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients underwent cardiac surgery

Exclusion criteria

  • Age < 18 years

Treatment and study plan

ECLS

Procedure

Emergency application of Extracorporeal Life Support in post-surgical patients

Primary outcomes

  1. Survival

    Time frame: 1 month after surgery

    Evaluate Early, mid and late Survival

  2. Survival

    Time frame: At 1 Year after surgery

    mid-time survival

  3. Survival

    Time frame: At 5 years after surgery

    late survival

Secondary outcomes

  1. Prognostic factors

    Time frame: Early: 1 month after surgery

    Identify early and late negative and positive prognostic factors

  2. Prognostic Factors

    Time frame: Late: 5 years after surgery

    Identify early and late negative and positive prognostic factors

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Collaborators

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

Registry information

Official study title

Outcomes' Predictors in Post-Surgery Extracorporeal Life Support

Acronym: PC-ECLS

Important dates

Study start
2004
Primary completion
2021
Study completion
2029
First posted
Apr 1, 2020
Registry last updated
Apr 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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