Quality of Life 1y and 2 y After VV-ECMO for COVID-19

NCT05780255 | Completed DMC

• 1 other identifier: COVID-19-ECMO BC-09806
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the quality of life and the outcome after veno-venous extracoporeal membrane oxygenation (ECMO) support fir severe acute respiratory syndrome (ARDS) in COVID-19 patients.

Conditions

COVID-19 Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation Complication; Quality of Life; Death

Keywords

ECMO; COVID-19; quality of life

Outcome Measures

Primary Outcomes (3)

• in-hospital mortality

  mortality during hospitalisation, up to two years

• Quality of life 1y after ECMO insertion

  Result of SF-36 1 year after VV-ECMO insertion

  1 year

• Quality of life 2y after ECMO insertion

  Result of SF-36 2 years after VV-ECMO insertion

  2 years

Secondary Outcomes (6)

• Lung complications requiring surgical treatment

  From the start of VV-ECMO support until weaning of VV-ECMO, up to two years

• Duration of mechanical ventilation

  2 years

• LOS ICU

  from the day of intensive care unit admission until the day of transfer to the ward, up to two years

• LOS hospital

  from the day of hospital admission until the day that the participant is transferred to home, up to two years

• death after hospital discharge

  after discharge from the hospital upon 2 years after

Study Arms (1)

COVID-19 positive patients

Patients with a PCR-confirmed COVID-19 infection, with ARDS and supported by VV-ECMO

Device: VV-ECMO

Interventions

VV-ECMO DEVICE

veno-venous extracorporeal membrane oxygenation

COVID-19 positive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with PCR-confirmed COVID-19 infection with ARDS who require veno-venous ECMO therapy.

You may qualify if:

• Patients with PCR-confirmed COVID-19 infection AND
• Acute Respiratory Distress Syndrome who require veno-venous ECMO therapy.

You may not qualify if:

• None

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent university hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Death; COVID-19

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Harlinde Peperstraete

  UZ Gent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 22, 2023
• Study Start: April 20, 2021
• Primary Completion: January 31, 2023
• Study Completion: February 1, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)