Nitric Oxide in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO)
NCT ID: NCT04224103
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
10 participants
OBSERVATIONAL
2019-08-08
2022-02-28
Brief Summary
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Detailed Description
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Stage 1 Patients in whom VA-ECMO is being initiated will be invited to participate. Hemodynamic, echocardiographic, and biochemical parameters will be measured immediately prior to iNO administration and repeated 30 minutes after iNO initiation. iNO will be continued for six hours to allow hemodynamic and oxygenation parameters to stabilize as per previous protocols in the literature. After six hours, hemodynamic, echocardiographic, and biochemical parameters will be re-assessed after which iNO will be discontinued. All parameters will be re-evaluated 30 minutes after iNO discontinuation.
Stage 2 A weaning trial will be performed at 1) the earliest signs of myocardial recovery or b) day 5. Myocardial recovery will be defined as: mean arterial pressure \> 60 millimeters of mercury (mmHg) on no or minimal inotropic/vasopressor support, arterial pulse pressure \> 10 mmHg, and minimal respiratory support (oxygen saturation \> 88% on \< 2 liters by nasal cannulae, or minimal ventilator setting if intubated). Inhaled nitric oxide will be re-initiated 30 minutes prior to the ECMO weaning trial. Adequacy of perfusion will be defined as a mixed venous oxygen saturation of \> 70%. Hemodynamic, echocardiographic, and biochemical parameter will be recorded immediately prior to iNO administration and then at 30 minutes prior to the ECMO weaning trial. ECMO will be weaned as per the standard protocol at the University Health Network with re-assessment of all parameters after weaning is complete. When ECMO weaning is unsuccessful, these parameters will be recorded immediately prior to re-initiation of full flow VA-ECMO and 30 minutes thereafter. VA-ECMO weaning will be re-attempted at 24-48 hours at the discretion of the medical team.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Inhaled nitric oxide
Inhaled nitric oxide
Stage 1: Patients in whom VA ECMO is being initiated will be invited to participate. Hemodynamic, echocardiographic, and biochemical parameters will be measured immediately prior to iNO administration, and thirty minutes after initiation. After six hours, hemodynamic, echocardiographic, and biochemical parameters will be re-assessed after which iNO will be weaned. All parameters will be re-evaluated 30 minutes after iNO discontinuation.
Stage 2: iNO will be re-initiated 30 minutes prior to the ECMO weaning trial. Hemodynamic, echocardiographic, and biochemical parameter will be recorded immediately prior to iNO administration and then at 30 minutes prior to the ECMO weaning trial. When ECMO weaning is unsuccessful, these parameters will be recorded immediately prior to re-initiation of full flow VA ECMO and 30 minutes thereafter. If successful, data will be collected after the wean and after iNO discontinuation.
Interventions
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Inhaled nitric oxide
Stage 1: Patients in whom VA ECMO is being initiated will be invited to participate. Hemodynamic, echocardiographic, and biochemical parameters will be measured immediately prior to iNO administration, and thirty minutes after initiation. After six hours, hemodynamic, echocardiographic, and biochemical parameters will be re-assessed after which iNO will be weaned. All parameters will be re-evaluated 30 minutes after iNO discontinuation.
Stage 2: iNO will be re-initiated 30 minutes prior to the ECMO weaning trial. Hemodynamic, echocardiographic, and biochemical parameter will be recorded immediately prior to iNO administration and then at 30 minutes prior to the ECMO weaning trial. When ECMO weaning is unsuccessful, these parameters will be recorded immediately prior to re-initiation of full flow VA ECMO and 30 minutes thereafter. If successful, data will be collected after the wean and after iNO discontinuation.
Eligibility Criteria
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Inclusion Criteria
* History or evidence of left ventricular failure
Exclusion Criteria
* Insufficient echocardiographic images to assess ventricular function
* Right ventricular assist device
* Uncorrected congenital heart disease
* Primary graft failure
* No cardiac output on bedside ECHO (LVEF\<5%)
* Pregnant or breastfeeding
18 Years
ALL
No
Sponsors
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Peter Munk Cardiac Center
UNKNOWN
Heart and Stroke Foundation of Canada
OTHER
University of Toronto
OTHER
Filio Billia
OTHER
Responsible Party
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Filio Billia
Director of Research, Peter Munk Cardiac Center
Principal Investigators
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Filio Billia, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto, Peter Munk Cardiac Centre
Locations
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Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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15-8770
Identifier Type: -
Identifier Source: org_study_id