Nitric Oxide in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO)

NCT04224103 | Unknown FDA Drug

• 1 other identifier: 15-8770
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Extracorporeal Membrane Oxygenation; Nitric Oxide; Shock, Cardiogenic

Keywords

Venoarterial ECMO; VA-ECMO weaning; Inhaled nitric oxide; Right ventricle

Outcome Measures

Primary Outcomes (5)

• Participant recruitment

  Recruitment of ten participants

  February 2020

• Right Heart - Qualitative function, change from baseline

  Mild/moderate/severe dysfunction as determined by reading echocardiographer

  After 6 hours of inhaled nitric oxide

• Right Heart - Tricuspid annular plane systolic excursion (TAPSE), change from baseline

  Measured in milimeters

  After 6 hours of inhaled nitric oxide

• Right Heart - RV fractional area change, change from baseline

  Measured in percent

  After 6 hours of inhaled nitric oxide

• Right Heart - longitudinal myocardial velocity (S'), change from baseline

  Measured in meters per second

  After 6 hours of inhaled nitric oxide

Secondary Outcomes (3)

• Left Heart Function

  After 6 hours of inhaled nitric oxide

• Weaning success

  Within 5 days of cannulation but may be repeated at 7 days if initially unsuccessful.

• Long-term RV function

  Within three months of initial ECMO cannulation.

Study Arms (1)

Inhaled nitric oxide

Drug: Inhaled nitric oxide

Interventions

Inhaled nitric oxide DRUG

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.

Inhaled nitric oxide

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Filio Billia: lead
• Peter Munk Cardiac Center: collaborator
• Heart and Stroke Foundation of Canada: collaborator
• University of Toronto: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G2C4, Canada

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Filio Billia, MD PhD

  University of Toronto, Peter Munk Cardiac Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea L Daly, MD

CONTACT

16475457454; andrealdaly@gmail.com

Katherine Tsang, RN BScN

CONTACT

14163403280; katherine.tsang@uhn.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Research, Peter Munk Cardiac Center

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: January 13, 2020
• Study Start: August 8, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)