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

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05780255
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Anticipated Duration (Months): 33.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Acute Respiratory Distress Syndrome; Extracorporeal Membrane Oxygenation Complication; Quality of Life; Death	Device: VV-ECMO

Detailed Description

The investigators follow our COVID-19 patients supported by ECMO, we make phone calls or real-life visits to pthe patients to score the quality of life, by using the SF-36. The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality , social functioning , role emotional , and mental health.

The participants are contacted 3 months, 6months, 1year and 2 years after the ECMO support started for evaluation of the SF-36.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 46 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Quality of Life 1y and 2 y After VV-ECMO for COVID-19, Measured by the 36-item Short Form Health Survey
• Actual Study Start Date: Apr 20, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 positive patients Patients with a PCR-confirmed COVID-19 infection, with ARDS and supported by VV-ECMO	Device: VV-ECMO; veno-venous extracorporeal membrane oxygenation

Outcome Measures

Primary Outcome Measures

1. in-hospital mortality [mortality during hospitalisation, up to two years]

2. Quality of life 1y after ECMO insertion [1 year]

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

3. Quality of life 2y after ECMO insertion [2 years]

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

Secondary Outcome Measures

1. Lung complications requiring surgical treatment [From the start of VV-ECMO support until weaning of VV-ECMO, up to two years]

   Hemothorax or lung abcedation

2. Duration of mechanical ventilation [2 years]

3. LOS ICU [from the day of intensive care unit admission until the day of transfer to the ward, up to two years]

   length of stay at the intensive care unit

4. LOS hospital [from the day of hospital admission until the day that the participant is transferred to home, up to two years]

   length of stay at the hospital

5. death after hospital discharge [after discharge from the hospital upon 2 years after]

   all-cause death

6. Incidence of acute kidney injury [from the day of hospital admission until the day that the participant is transferred to home, up to two years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with PCR-confirmed COVID-19 infection AND

• Acute Respiratory Distress Syndrome who require veno-venous ECMO therapy.

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ghent university hospital	Ghent		Belgium	9000

Sponsors and Collaborators

• University Hospital, Ghent

Investigators

• Principal Investigator: Harlinde Peperstraete, UZ Gent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT05780255
• Other Study ID Numbers: COVID-19-ECMO BC-09806
• First Posted: Mar 22, 2023
• Last Update Posted: Mar 22, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Ghent: ECMO; COVID-19; quality of life
• Additional relevant MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury

Study Results

No Results Posted as of Mar 22, 2023