A Randomised Controlled Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

• Moderate to severe respiratory failure, as demonstrated by two P:F ratios \<150mmHg at least 6 hours apart. Arterial Blood Gases (ABG) with P:F ratio \> 150mmHg are permitted between the two trial inclusion ABGs.

• Trial of proning (unless contraindicated)

Locations
Other Locations
Australia
The Prince Charles Hospital
RECRUITING
Brisbane
St Vincent's Hospital Sydney
RECRUITING
Darlinghurst
Gold Coast University Hospital
RECRUITING
Gold Coast
The Alfred Hospital
RECRUITING
Melbourne
Fiona Stanley Hospital
NOT_YET_RECRUITING
Perth
Royal Prince Alfred
RECRUITING
Sydney
Germany
Charite Universitatmedizin
RECRUITING
Berlin
Contact Information
Primary
Stephanie M Hunter
Stephanie.Hunter@monash.edu
+61 3 9903 0646
Backup
Tony Trapani
Tony.Trapani@monash.edu
+61 3 9903 0343
Time Frame
Start Date: 2022-11-28
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 140
Treatments
Active_comparator: Venovenous ECMO
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,
No_intervention: Standard care
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.
Sponsors
Leads: Australian and New Zealand Intensive Care Research Centre
Collaborators: The Alfred

This content was sourced from clinicaltrials.gov

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