Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19

Completed

• Conditions: COVID-19
• Interventions: Procedure: ECMO

• Registration Number: NCT05158816
• Lead Sponsor: Jessa Hospital

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 ..

Study Timeline

• Study Start: 2021-09-08
• Study First Submitted: 2021-12-10
• Study First Submitted QC: 2021-12-14
• Study First Posted: 2021-12-15
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 295

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COVID-19 patients	ECMO	COVID-19 patients admitted to the ICU

Primary Outcome Measures

Name	Time	Method
Mortality	through study completion, an average of 1 year	mortality of patients during their stay at the ICU

Secondary Outcome Measures

Name	Time	Method
3 Months Mortality	3 months after admission to ICU	Mortality of patients
Length of stay in ICU	during ICU stay	Length of stay in ICU
acute kidney injury	through study completion, an average of 1 year	incidence of acute kidney injury
continous renal replacement therapy	through study completion, an average of 1 year	incidence of continous renal replacement therapy
Length of stay in hospital	through study completion, an average of 1 year	Length of stay in hospital

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium