NCT05158816

Brief Summary

Retrospective single center analyses of COVID-19 patients admitted to the ICU between 01/02/2020 and 31/07/2021.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
295

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

December 10, 2021

Last Update Submit

December 20, 2022

Conditions

Keywords

ECMO

Outcome Measures

Primary Outcomes (1)

  • Mortality

    mortality of patients during their stay at the ICU

    through study completion, an average of 1 year

Secondary Outcomes (5)

  • 3 Months Mortality

    3 months after admission to ICU

  • acute kidney injury

    through study completion, an average of 1 year

  • continous renal replacement therapy

    through study completion, an average of 1 year

  • Length of stay in hospital

    through study completion, an average of 1 year

  • Length of stay in ICU

    during ICU stay

Other Outcomes (1)

  • Complications

    through study completion, an average of 1 year

Study Arms (1)

COVID-19 patients

COVID-19 patients admitted to the ICU

Procedure: ECMO

Interventions

ECMOPROCEDURE

Patients undergoing extracorporeal membrane oxygenation

COVID-19 patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult COVID-19 patients (\>18 years) admitted to the ICU between 01/02/2020 and 31/07/2021 with a laboratory confirmation of COVID-19 infection with a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage

You may qualify if:

  • All adult COVID-19 patients (\>18 years) admitted to the ICU between 01/02/2020 and 31/07/2021 with a laboratory confirmation of COVID-19 infection with a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage

You may not qualify if:

  • All adult patients admitted for other reasons to the ICU (no COVID-19 pneumonia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

Location

Related Publications (2)

  • Madrid-Valero JJ, Ware J, Allen JM, Boughton CK, Hartnell S, Wilinska ME, Thankamony A, de Beaufort C, Schierloh U, Campbell FM, Sibayan J, Bocchino LE, Kollman C, Hovorka R, Gregory AM, Consortium K. Sleep Quality and Quantity in Caregivers of Children with Type 1 Diabetes Using Closed-Loop Insulin Delivery or a Sensor-Augmented Pump. Pediatr Diabetes. 2023 Jun 13;2023:7937007. doi: 10.1155/2023/7937007. eCollection 2023.

  • Stessel B, Bin Saad M, Ullrick L, Geebelen L, Lehaen J, Timmermans PJ, Van Tornout M, Callebaut I, Vandenbrande J, Dubois J. Extracorporeal Membrane Oxygenation to Support COVID-19 Patients: A Propensity-Matched Cohort Study. Crit Care Res Pract. 2023 Jun 12;2023:5101456. doi: 10.1155/2023/5101456. eCollection 2023.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 10, 2021

First Posted

December 15, 2021

Study Start

September 8, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

December 21, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations