Extracorporeal Membrane OxygenationNOVICENCT04224103
Nitric Oxide in Venoarterial Extracorporeal Membrane Oxygenation (VA ECMO)
An observational study of Extracorporeal Membrane Oxygenation and Nitric Oxide, run by Filio Billia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Membrane Oxygenation, Nitric Oxide, Shock, Cardiogenic
- What is being tested?
- Inhaled nitric oxide
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 8 Aug 2019to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Age>18years
- History or evidence of left ventricular failure
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G2C4
Andrea Daly, MD, 16475457454, andrealdaly@gmail.com
Katherine Tsang, RN BScN, 14163403280, katherine.tsang@uhn.ca
About this study
Official title: Nitric Oxide in Right Ventricular Dysfunction: Improvements in Clinical and Hemodynamic Parameters on Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO; NOVICE)
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).
Read the 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.
- Being tested
- Inhaled nitric oxide
- Keywords
- Venoarterial ECMO, VA-ECMO weaning, Inhaled nitric oxide, Right ventricle
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled nitric oxideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled nitric oxide | Not described Receives: Drug: Inhaled nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment
Recruitment of ten participants
Measured: February 2020
Right Heart - Qualitative function, change from baseline
Mild/moderate/severe dysfunction as determined by reading echocardiographer
Measured: After 6 hours of inhaled nitric oxide
Right Heart - Tricuspid annular plane systolic excursion (TAPSE), change from baseline
Measured in milimeters
Measured: After 6 hours of inhaled nitric oxide
Right Heart - RV fractional area change, change from baseline
Measured in percent
Measured: After 6 hours of inhaled nitric oxide
Right Heart - longitudinal myocardial velocity (S'), change from baseline
Measured in meters per second
Measured: After 6 hours of inhaled nitric oxide
Secondary outcomes (3)
Left Heart Function
Left ventricular ejection fraction
Measured: After 6 hours of inhaled nitric oxide
Weaning success
Explore the effect of iNO on the rate of successful VA ECMO weaning.
Measured: Within 5 days of cannulation but may be repeated at 7 days if initially unsuccessful.
Long-term RV function
Assess RV function after LVAD implantation or cardiac transplantation if these occur during the same hospitalization.
Measured: Within three months of initial ECMO cannulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start8 Aug 2019
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane OxygenationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Filio Billia
- Sponsor type
- University, hospital or other
- Collaborators
- Peter Munk Cardiac Center, Heart and Stroke Foundation of Canada, University of Toronto
- Responsible party
- Sponsor-investigator, Filio Billia, University of Toronto
- Investigators
- Filio Billia, MD PhD, Principal investigator, University of Toronto, Peter Munk Cardiac Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224103
- Sponsor's protocol ID
- 15-8770
- Acronym
- NOVICE
- Status last verified
- Nov 2020
- First submitted
- 16 Sep 2019
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nitric Oxide in Right Ventricular Dysfunction: Improvements in Clinical and Hemodynamic Parameters on Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO; NOVICE)
- ClinicalTrials.gov ID
- NCT04224103
- Acronym / sponsor ID
- NOVICE / 15-8770
- Keywords
- Venoarterial ECMO, VA-ECMO weaning, Inhaled nitric oxide, Right ventricle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Filio BilliaUniversity, hospital or other
- Collaborators
- Peter Munk Cardiac Center, Heart and Stroke Foundation of Canada, University of Toronto
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inhaled nitric oxide | – | Drug: Inhaled nitric oxide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Age>18years
- History or evidence of left ventricular failure
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled nitric oxideStage 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. | Drug | Inhaled nitric oxide |
Primary outcome
Participant recruitment
Time frame: February 2020
Recruitment of ten participants
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
Right Heart - Tricuspid annular plane systolic excursion (TAPSE), change from baseline
Time frame: After 6 hours of inhaled nitric oxide
Measured in milimeters
Right Heart - RV fractional area change, change from baseline
Time frame: After 6 hours of inhaled nitric oxide
Measured in percent
Right Heart - longitudinal myocardial velocity (S'), change from baseline
Time frame: After 6 hours of inhaled nitric oxide
Measured in meters per second
3 secondary outcomes
Left Heart Function
Time frame: After 6 hours of inhaled nitric oxide
Weaning success
Time frame: Within 5 days of cannulation but may be repeated at 7 days if initially unsuccessful.
Long-term RV function
Time frame: Within three months of initial ECMO cannulation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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Drug Effect
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Filio Billia, MD PhD principal investigator
University of Toronto, Peter Munk Cardiac Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Extracorporeal Membrane Oxygenation and Nitric Oxide, run by Filio Billia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea L Daly, MD (16475457454, andrealdaly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment (time frame: February 2020). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.