Post-Surgery Extracorporeal Life Support | NCT04330651

Studies
Post-Surgery Extracorporeal Life Support

NCT04330651

Sponsor

University of Florence

Status

Recruiting

Last Update Posted

Apr 28, 2021Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

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

Interventions

ECLS

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Mar 19, 2021Actual

Completion Date

Jan 31, 2029Estimated

First Submitted Date

Mar 19, 2020

First Submission Date that Met QC Criteria

Mar 31, 2020

First Posted Date

Apr 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2021

Last Update Posted Date

Apr 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Massimo Bonacchi, Professor, University of FlorencePrincipal Investigator

Lead Sponsor

University of FlorenceOTHER

Collaborators

Name	Class
Sandro Gelsomino	UNKNOWN
Edvin Prifti	UNKNOWN
Francesco Cabrucci	UNKNOWN
Marco Bugetti

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECLS	Procedure	Emergency application of Extracorporeal Life Support in post-surgical patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Prognostic factors	Identify early and late negative and positive prognostic factors	Early: 1 month after surgery
Prognostic Factors	Identify early and late negative and positive prognostic factors

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients underwent cardiac surgery

Exclusion Criteria:

Age < 18 years

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients underwent cardiac surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massimo Bonacchi	Recruiting	Florence		50144	Italy

Condition Browse Module

MeSH Terms

ID	Term
D012770	Shock, Cardiogenic
D000080942	Post-Cardiac Arrest Syndrome

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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