Post-Surgery Extracorporeal Life Support

NCT04330651 | Recruiting

• 1 other identifier: PC-ECLS Study
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

extracorporeal life support; ecls; ecmo; outocome; prognostic factors; extracorporeal membrane oxygenation

Outcome Measures

Primary Outcomes (3)

• Survival

  Evaluate Early, mid and late Survival

  1 month after surgery

• Survival

  mid-time survival

  At 1 Year after surgery

• Survival

  late survival

  At 5 years after surgery

Secondary Outcomes (2)

• Prognostic factors

  Early: 1 month after surgery

• Prognostic Factors

  Late: 5 years after surgery

Interventions

ECLS PROCEDURE

Emergency application of Extracorporeal Life Support in post-surgical patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients underwent cardiac surgery

You may qualify if:

• Patients underwent cardiac surgery

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• University of Florence: lead
• Sandro Gelsomino: collaborator
• Edvin Prifti: collaborator
• Francesco Cabrucci: collaborator
• Marco Bugetti: collaborator
• Orlando Parise: collaborator
• Aleksander Dokollari: collaborator

Study Sites (1)

Massimo Bonacchi

Florence, 50144, Italy

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic; Post-Cardiac Arrest Syndrome

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Reperfusion Injury; Postoperative Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: April 1, 2020
• Study Start: January 1, 2004
• Primary Completion: March 19, 2021
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

IT (1)