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Nitric Oxide in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO)

NCT04224103 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2020-11-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Peter Munk Cardiac Center

    collaborator UNKNOWN

  • Heart and Stroke Foundation of Canada

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Filio Billia

    lead OTHER

Principal Investigators

  • Filio Billia, MD PhD · University of Toronto, Peter Munk Cardiac Centre

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-08
Primary Completion
2022-02-28
Completion
2022-02-28
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04224103 on ClinicalTrials.gov