Extracorporal Membrane Oxygenation for Critically Ill Pat... | NCT05158816

Studies
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19

NCT05158816

Sponsor

Jessa Hospital

Status

Completed

Last Update Posted

Dec 21, 2022Actual

Enrollment

295Actual

Phase

Not provided

Conditions

COVID-19

Interventions

ECMO

Countries

Belgium

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

Dec 2022

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

Sep 8, 2021Actual

Primary Completion Date

Nov 30, 2022Actual

Completion Date

Nov 30, 2022Actual

First Submitted Date

Dec 10, 2021

First Submission Date that Met QC Criteria

Dec 14, 2021

First Posted Date

Dec 15, 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

Dec 20, 2022

Last Update Posted Date

Dec 21, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stessel Björn, Principal Investigator, Jessa HospitalPrincipal Investigator

Lead Sponsor

Jessa HospitalOTHER

Collaborators

Not provided

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

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

Detailed Description

All adults (>18 years) with acute hypoxaemic respiratory failure due to diagnosed COVID-19 pneumonia and admitted to ICU from 01/02/2020 until 31/07/2021 were included in the study. Following the World Health Organisation (WHO) protocol 19, laboratory confirmation of COVID-19 infection was defined as a positive result on polymerase chain reaction (PCR) assays of nasopharyngeal swab samples or bronchoalveolar lavage. Only laboratory-confirmed patients were included in the analysis.

Additional data collection

Additional collected parameters are listed below and are collected as a standard-of-care in our hospital:

Demographics: i.e age, gender, BMI
DNR code
Comorbidities: smoking, obesity, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure (AKI), liver failure, gastrointestinal disease, neurological conditions, mental state, other
Symptoms at the time of admission to ICU: i.e fever, body temperature, dyspnoea, headache, diarrhea etc…
Laboratory results of all standard parameters measured
Treatment: antiviral agents, antibiotics, etc…
Complications: shock, heart failure, sepsis, stroke, etc…
Ventilation: method, PEEP, FiO2, P/F ratio ..

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

295Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COVID-19 patients		COVID-19 patients admitted to the ICU	Procedure: ECMO

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ECMO	Procedure	Patients undergoing extracorporeal membrane oxygenation	COVID-19 patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	mortality of patients during their stay at the ICU	through study completion, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
3 Months Mortality	Mortality of patients	3 months after admission to ICU
acute kidney injury	incidence of acute kidney injury	through study completion, an average of 1 year

Other Outcomes

Measure	Description	Time Frame
Complications	description of possible complications after ECMO	through study completion, an average of 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jessa Hospital		Hasselt	Limburg	3500	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40303271	Derived	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.
37342313

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