Menu
Recruiting NCT04330651

Post-Surgery Extracorporeal Life Support

Observational Cardiogenic Shock Extracorporeal Life Support Extracorporeal Membrane Oxygenation Complication Post Cardiac Arrest Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ECLS.
Who it may be relevant to
Registry conditions: Cardiogenic Shock, Extracorporeal Life Support, Extracorporeal Membrane Oxygenation Complication, Post Cardiac Arrest Syndrome. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Outcomes' Predictors in Post-Surgery Extracorporeal Life Support

Overview

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.

Interventions

  • Procedure ECLS
    Emergency application of Extracorporeal Life Support in post-surgical patients

Primary outcome measures

  • Survival [Time frame: 1 month after surgery]
  • Survival [Time frame: At 1 Year after surgery]
  • Survival [Time frame: At 5 years after surgery]
Secondary outcome measures (2)
  • Prognostic factors [Time frame: Early: 1 month after surgery]
  • Prognostic Factors [Time frame: Late: 5 years after surgery]

Eligibility criteria

Inclusion criteria

  • Patients underwent cardiac surgery

Exclusion criteria

  • Age < 18 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Massimo Bonacchi — Florence

Identifiers

NCT: NCT04330651 · PC-ECLS Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗