Early Versus Late ECMO Therapy in COVID-19 Induced ARDS (ECMO-VID)

NCT04341285 | Withdrawn DMC

• 1 other identifier: ECMO-VID
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit. Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias. Duration of intervention per patient: varies, depending on severity of pulmonary compromise Follow-up per patient: Until hospital discharge Accompanying measures: Serum Samples and bronchoscopy samples of patients included into the trial for secondary analysis of inflammatory parameters and potential biomarkers

Conditions

ARDS, Human; COVID-19

Outcome Measures

Primary Outcomes (1)

• 28 day all cause mortality

  survival in 28-day follow-up period (28 day all cause mortality)

  28 Days

Secondary Outcomes (7)

• 90 day all cause mortality

  90 days

• Sepsis-related organ failure assessment score at day 1-14, 28 and 90 days

  day 1-14, 28 and 90

• duration of mechanical ventilation support

  28 days

• Ventilator Associated Pneumonia

  28 days

• Bleeding complications

  28 das

Study Arms (2)

Early ECMO

ACTIVE COMPARATOR

Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit.

Procedure: ECMO Implantation

Late ECMO

ACTIVE COMPARATOR

Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias.

Procedure: ECMO Implantation

Interventions

ECMO Implantation PROCEDURE

Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit.

Early ECMO; Late ECMO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID-19positive(+) ARDS as defined according to the Berlin Definition
• ratio of partial pressure arterial oxygen and fraction of inspired oxygen (PaO2/ FiO2) ≤100
• Bilateral opacities consistent with pulmonary edema on frontal chest radiograph
• requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
• no clinical evidence of left atrial hypertension, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
• ≤ 7 days from the initiation of mechanical ventilation at the time of randomization. - Patients must be enrolled within 96 hours of onset of ARDS -

You may not qualify if:

• COVID-19negative(-) ARDS
• Age less than 18 years
• More than 7 days since initiation of mechanical ventilation
• more than 96 hours since meeting ARDS criteria
• patient, surrogate or physician not committed to full intensive care support.
• pregnancy

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• University Hospital Freiburg: collaborator
• RWTH Aachen University: collaborator
• University Hospital Muenster: collaborator

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections

Study Officials

• Peter Rosenberger, Prof.

  +4970712986622

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours Control intervention: Insertion of Extracorporal Membrane Oxygenation (ECMO) as rescue therapy following failure of conventional therapy for ARDS. This conventional therapy will be standardized to reduce bias. Duration of intervention per patient: varies, depending on severity of pulmonary compromise Follow-up per patient: 90days or until hospital discharge Accompanying measures: Serum Samples and bronchoscopy samples of patients included into the trial for secondary analysis of inflammatory parameters and potential biomarkers

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 10, 2020
• Study Start: August 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 9, 2021

Record last verified: 2020-06

Locations

DE (1)