ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS | NCT05080933

Studies
ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS

NCT05080933

Sponsor

University of Turin, Italy

Status

Completed

Last Update Posted

Oct 18, 2021Actual

Enrollment

308Actual

Phase

Not provided

Conditions

ARDS
COVID-19
H1N1 Influenza

Interventions

Not provided

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

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2009Actual

Primary Completion Date

Feb 28, 2021Actual

Completion Date

Feb 28, 2021Actual

First Submitted Date

Oct 15, 2021

First Submission Date that Met QC Criteria

Oct 15, 2021

First Posted Date

Oct 18, 2021Actual

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

Oct 15, 2021

Last Update Posted Date

Oct 18, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support.

Research question: To compare outcome of patients who required VV ECMO for Covid19 and H1N1 associated ARDS

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

308Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All cause mortality on day 60 after ECMO initiation		60 days

Secondary Outcomes

Measure	Description	Time Frame
Hospital length of stay		90 days
ICU length of stay		90 days
Hospital mortality on day 90 after ECMO initiation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19 or influenza A H1N1 (suspected or confirmed) diagnosis
Severe ARDS (according to Berlin Definition)
VV ECMO
Invasive mechanical ventilation through endotracheal tube or tracheostomy

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 who required VV ECMO for COVID-19 and influenza A H1N1 associated ARDS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino		Turin		10126	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35123562	Derived	Fanelli V, Giani M, Grasselli G, Mojoli F, Martucci G, Grazioli L, Alessandri F, Mongodi S, Sales G, Montrucchio G, Pizzi C, Richiardi L, Lorini L, Arcadipane A, Pesenti A, Foti G, Patroniti N, Brazzi L, Ranieri V. Extracorporeal membrane oxygenation for COVID-19 and influenza H1N1 associated acute respiratory distress syndrome: a multicenter retrospective cohort study. Crit Care. 2022 Feb 5;26(1):34. doi: 10.1186/s13054-022-03906-4.

ID	Term
D000086382	COVID-19
D009976	Orthomyxoviridae Infections

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections