Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19

COVID-19 Clinical Trial

Official title:

Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19: a Single Centre Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05158816
• Other study ID #: f/2021/097
• Status: Completed
• Start date: September 8, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: December 2022
• Source: Jessa Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 ..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• COVID-19

Intervention

Procedure:
• ECMO
Patients undergoing extracorporeal membrane oxygenation

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications	description of possible complications after ECMO	through study completion, an average of 1 year
Primary	Mortality	mortality of patients during their stay at the ICU	through study completion, an average of 1 year
Secondary	3 Months Mortality	Mortality of patients	3 months after admission to ICU
Secondary	acute kidney injury	incidence of acute kidney injury	through study completion, an average of 1 year
Secondary	continous renal replacement therapy	incidence of continous renal replacement therapy	through study completion, an average of 1 year
Secondary	Length of stay in hospital	Length of stay in hospital	through study completion, an average of 1 year
Secondary	Length of stay in ICU	Length of stay in ICU	during ICU stay