Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19

• Sponsor: Jessa Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05158816
• Collaborator: (none)
• Enrollment: 295
• Location: 1
• Anticipated Duration (Months): 15.7
• Patients Per Site Per Month: 18.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Procedure: ECMO

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 ..

Study Design

• Study Type: Observational
• Actual Enrollment: 295 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19: a Single Centre Analysis
• Actual Study Start Date: Sep 8, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
COVID-19 patients COVID-19 patients admitted to the ICU	Procedure: ECMO; Patients undergoing extracorporeal membrane oxygenation

Outcome Measures

Primary Outcome Measures

1. Mortality [through study completion, an average of 1 year]

   mortality of patients during their stay at the ICU

Secondary Outcome Measures

1. 3 Months Mortality [3 months after admission to ICU]

   Mortality of patients

2. acute kidney injury [through study completion, an average of 1 year]

   incidence of acute kidney injury

3. continous renal replacement therapy [through study completion, an average of 1 year]

   incidence of continous renal replacement therapy

4. Length of stay in hospital [through study completion, an average of 1 year]

   Length of stay in hospital

5. Length of stay in ICU [during ICU stay]

   Length of stay in ICU

Other Outcome Measures

1. Complications [through study completion, an average of 1 year]

   description of possible complications after ECMO

Eligibility Criteria

Criteria

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

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jessa Hospital	Hasselt	Limburg	Belgium	3500

Sponsors and Collaborators

• Jessa Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stessel Björn, Principal Investigator, Jessa Hospital
• ClinicalTrials.gov Identifier: NCT05158816
• Other Study ID Numbers: f/2021/097
• First Posted: Dec 15, 2021
• Last Update Posted: Dec 15, 2021
• Last Verified: Dec 1, 2021

• 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 Stessel Björn, Principal Investigator, Jessa Hospital: ECMO
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Dec 15, 2021