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Trial record 1 of 1 for:    NCT04224103
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Nitric Oxide in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO) (NOVICE)

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ClinicalTrials.gov Identifier: NCT04224103
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
Peter Munk Cardiac Center
Heart and Stroke Foundation of Canada
University of Toronto
Information provided by (Responsible Party):
Filio Billia, University of Toronto

Brief Summary:
This pilot study is designed to investigate the effect of inhaled nitric oxide on cardiac, pulmonary artery, and systemic hemodynamics at various time points during venoarterial extracorporeal membrane oxygenation (VA-ECMO) support. Patients who have been initiated on VA-ECMO will be invited to participate. Inhaled nitric oxide (iNO) will be used early after VA-ECMO cannulation (once consent is obtained). After baseline hemodynamic, biochemical, and echocardiographic parameters are assessed, iNO will be initiated and all parameters will be reassessed after 30 minutes and 6 hours. Inhaled nitric oxide will then be discontinued and all parameters repeated. At the time of VA-ECMO weaning (timing determined by clinical team), iNO will be reinitiated with repeat assessment of hemodynamic, biochemical, and echocardiographic parameters both prior to the wean and after the wean (whether successful or not).

Condition or disease Intervention/treatment
Extracorporeal Membrane Oxygenation Nitric Oxide Shock, Cardiogenic Drug: Inhaled nitric oxide

Detailed Description:

This is a proof of concept, pilot, phase II study using iNO in patients on VA-ECMO. Stage 1 will assess the participant's response to iNO early after cannulation. Stage 2 will assess the participant's response to iNO during the ECMO weaning process.

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.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Nitric Oxide in Right Ventricular Dysfunction: Improvements in Clinical and Hemodynamic Parameters on Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO; NOVICE)
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Inhaled nitric oxide Drug: 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.





Primary Outcome Measures :
  1. Participant recruitment [ Time Frame: February 2020 ]
    Recruitment of ten participants

  2. Right Heart - Qualitative function, change from baseline [ Time Frame: After 6 hours of inhaled nitric oxide ]
    Mild/moderate/severe dysfunction as determined by reading echocardiographer

  3. Right Heart - Tricuspid annular plane systolic excursion (TAPSE), change from baseline [ Time Frame: After 6 hours of inhaled nitric oxide ]
    Measured in milimeters

  4. Right Heart - RV fractional area change, change from baseline [ Time Frame: After 6 hours of inhaled nitric oxide ]
    Measured in percent

  5. Right Heart - longitudinal myocardial velocity (S'), change from baseline [ Time Frame: After 6 hours of inhaled nitric oxide ]
    Measured in meters per second


Secondary Outcome Measures :
  1. Left Heart Function [ Time Frame: After 6 hours of inhaled nitric oxide ]
    Left ventricular ejection fraction

  2. Weaning success [ Time Frame: Within 5 days of cannulation but may be repeated at 7 days if initially unsuccessful. ]
    Explore the effect of iNO on the rate of successful VA ECMO weaning.

  3. Long-term RV function [ Time Frame: Within three months of initial ECMO cannulation. ]
    Assess RV function after LVAD implantation or cardiac transplantation if these occur during the same hospitalization.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be comprised of participants with decompensated heart failure in whom VA ECMO is being used as a bridge to recovery, cardiac transplantation, or durable mechanical circulatory support (MCS).
Criteria

Inclusion Criteria:

  • Age>18years
  • History or evidence of left ventricular failure

Exclusion Criteria:

  • ECMO cannulation site other than the femoral vein and artery
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04224103


Contacts
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Contact: Andrea L Daly, MD 16475457454 andrealdaly@gmail.com
Contact: Katherine Tsang, RN BScN 14163403280 katherine.tsang@uhn.ca

Locations
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Canada, Ontario
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G2C4
Contact: Andrea Daly, MD    16475457454    andrealdaly@gmail.com   
Contact: Katherine Tsang, RN BScN    14163403280    katherine.tsang@uhn.ca   
Sponsors and Collaborators
Filio Billia
Peter Munk Cardiac Center
Heart and Stroke Foundation of Canada
University of Toronto
Investigators
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Principal Investigator: Filio Billia, MD PhD University of Toronto, Peter Munk Cardiac Centre
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Responsible Party: Filio Billia, Director of Research, Peter Munk Cardiac Center, University of Toronto
ClinicalTrials.gov Identifier: NCT04224103    
Other Study ID Numbers: 15-8770
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Filio Billia, University of Toronto:
Venoarterial ECMO
VA-ECMO weaning
Inhaled nitric oxide
Right ventricle
Additional relevant MeSH terms:
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Shock, Cardiogenic
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Infarction
Ischemia
Pathologic Processes
Necrosis
Shock
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents