Recruiting

Nitric OxideNitric Oxide in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO)

Sponsor:

Filio Billia

Code:

NCT04224103

Conditions

Extracorporeal Membrane Oxygenation

Nitric Oxide

Shock, Cardiogenic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Inhaled nitric oxide

Study Details

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

Study ID

NCT04224103

Start date

Aug 8, 2019

Status verified date

Nov, 2020

Completion date

Feb 28, 2022

Anticipated

Primary completion date

Feb 28, 2022

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Inhaled nitric oxide

Interventions

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 measure

Participant recruitment [ Time Frame: February 2020 ]
Right Heart - Qualitative function, change from baseline [ Time Frame: After 6 hours of inhaled nitric oxide ]
Right Heart - Tricuspid annular plane systolic excursion (TAPSE), change from baseline [ Time Frame: After 6 hours of inhaled nitric oxide ]
Right Heart - RV fractional area change, change from baseline [ Time Frame: After 6 hours of inhaled nitric oxide ]
Right Heart - longitudinal myocardial velocity (S'), change from baseline [ Time Frame: After 6 hours of inhaled nitric oxide ]

Central Contacts and Locations

Central contacts

Andrea L Daly, MD

16475457454 andrealdaly@gmail.com

Katherine Tsang, RN BScN

14163403280 katherine.tsang@uhn.ca

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G2C4

Contacts

Andrea Daly, MD

16475457454 andrealdaly@gmail.com

Katherine Tsang, RN BScN

14163403280 katherine.tsang@uhn.ca

More Information

Sponsor

Filio Billia

Last update posted

Nov 4, 2020

Last verified

Nov, 2020

Keywords

Venoarterial ECMO
VA-ECMO weaning
Inhaled nitric oxide
Right ventricle

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Filio Billia on 2020-11-04.