NCT05562505

Brief Summary

To determine whether a strategy of adding venovenous ECMO to mechanical ventilation, as compared to mechanical ventilation alone, increases the number of intensive care free days at day 60, in patients with moderate to severe acute hypoxic respiratory failure.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Nov 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

7 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Nov 2022Jan 2027

First Submitted

Initial submission to the registry

September 11, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 30, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 28, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

3.7 years

First QC Date

September 11, 2022

Last Update Submit

August 6, 2024

Conditions

Mechanical Ventilation ComplicationHypoxemiaAcute Respiratory Distress Syndrome Due to COVID-19COVID-19 Respiratory InfectionPneumoniaExtracorporeal Membrane Oxygenation

Keywords

Intensive Care UnitECMOExtracorporeal Membrane OxygenationMechanical VentilationEarly ECMO

Outcome Measures

Primary Outcomes (1)

  • Intensive Care Unit Free days to Day 60

    Days alive and free from ICU to Day 60. Day Day 0 is randomisation day, with any portion of a day is spent in an ICU counted as a day.

    60 Days

Secondary Outcomes (1)

  • Daily sedation scores

    Day 28

Other Outcomes (5)

  • Extubation rates

    Day 28

  • Participation in early mobilisation

    Day 28

  • Number of Participants who were randomised to standard care initially and subsequently needed VV-ECMO.

    Day 28

  • +2 more other outcomes

Study Arms (2)

Venovenous ECMO

ACTIVE COMPARATOR

Patients allocated to the ECMO strategy be initiated on V-V ECMO and on anticoagulation (blood thinning medication to prevent clot formation) within 24 hours of being allocated into the intervention group. Anticoagulant medication to prevent clot formation will be initiated as per current local practice for each site. Sites are encouraged to use best practice ECMO management that includes de-sedation, extubation, commencement of physiotherapy and rehabilitation,

Other: Venovenous ECMO

Standard care

NO INTERVENTION

Patients allocated to the standard care arm will receive routine intensive care for hypoxic respiratory failure, including mechanical ventilation as per local practices, weaning of sedation and assessment for extubation. Patients who continue to deteriorate will be eligible for initiation of V-V ECMO if they meet the ECMO to rescue lung injury in severe ARDS (EOLIA) criteria: Partial pressures of arterial oxygen (PaO2):Fraction of inspired oxygen (FiO2)\<50 for 3 hours, PaO2:FiO2\<80 for 6 hours, pH\<7.25 with PaCO2 \>60 for \>6 hours.

Interventions

Venovenous ECMOOTHER

ECMO therapy for patients with hypoxic respiratory failure.

Venovenous ECMO

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 to 65 years old
  • Acute hypoxemic respiratory failure characterised by new or worsening respiratory symptoms developing within 2 weeks prior to the onset of need for oxygen or respiratory support
  • Mechanical ventilation of \<7 days
  • Trial of proning (unless contraindicated)

You may not qualify if:

  • The patient will be extubated today or tomorrow (i.e. will not remain intubated and ventilated the day after tomorrow)
  • Cardiogenic cause of respiratory failure
  • Chronic hypercapnic respiratory failure defined as PaCO2 \> 60 mmHg in the outpatient setting
  • Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep disordered breathing
  • Confirmed diffuse alveolar haemorrhage from vasculitis
  • Neurologic conditions, i.e. undergoing treatment for intracranial hypertension
  • Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybrid configuration)
  • Patient needing immediate VV ECMO (as per EOLIA criteria)
  • The patient is moribund and deemed unlikely to survive past 24 hours (as determined by the clinical team)
  • The patient is being transitioned to palliative care
  • Contraindications to anticoagulation (e.g., active GI bleeding, bleeding predisposition, severe trauma)
  • Previous hypersensitivity/anaphylactic reaction to heparin or heparin-induced thrombocytopenia
  • Participation or Consent is declined, OR
  • Unable to identify or Contact surrogate decision maker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

St Vincent's Hospital Sydney

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Royal Prince Alfred

Sydney, New South Wales, Australia

RECRUITING

The Prince Charles Hospital

Brisbane, Queensland, Australia

RECRUITING

Gold Coast University Hospital

Gold Coast, Queensland, 4217, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Fiona Stanley Hospital

Perth, Western Australia, 6150, Australia

NOT YET RECRUITING

Charite Universitatmedizin

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

HypoxiaPneumonia

Interventions

Extracorporeal Membrane Oxygenation

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeuticsExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

  • Aidan Burrell, MBBS

    Monash University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie M Hunter

CONTACT

+61 3 9903 0646Stephanie.Hunter@monash.edu

Tony Trapani

CONTACT

+61 3 9903 0343Tony.Trapani@monash.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2022

First Posted

September 30, 2022

Study Start

November 28, 2022

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

August 9, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

The Management Committee support the view of the International Committee of Medical Journal Editors and the World Health Organisation (WHO) with reference to the ethical obligation to responsibly share data acquired by interventional clinical trials. At the conclusion of the study, the management committee will consider requests from researchers who provide a methodically sound scientific proposal as per the Data Sharing Policy set out in the Australian and New Zealand Intensive Care Research Centre (ANZIC-RC) Terms of Reference. Only de-identified data will be shared and all requests for data must comply with the ethical, regulatory, and legislative requirements governing their jurisdiction.

Locations

DE(1)AU(6)