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Nitric Oxide for Endothelial Dysfunction
Phase 2
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pvr will be measured every 6 hours after surgery for 24 hours after cardiopulmonary bypass start.
Awards & highlights
Study Summary
This trial will assess the effects of Nitric Oxide on vascular responsiveness and on endothelial function during hemolysis in patients with pre-operative endothelial dysfunction undergoing cardiac surgery requiring prolonged cardiopulmonary bypass.
Eligible Conditions
- Endothelial Dysfunction
- Cardiovascular Disease
- Intravascular Hemolysis
- Cardiovascular Risk
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ svr will be measured every 6 hours after surgery for 24 hours after cardiopulmonary bypass start.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~svr will be measured every 6 hours after surgery for 24 hours after cardiopulmonary bypass start.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reactive Hyperemia Index (RHI)
Other outcome measures
Endothelial Nitric Oxide Synthase (eNOS) enzymatic activity
Pulmonary vascular resistances (PVR)
Systemic vascular resistances (SVR)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nitric OxideExperimental Treatment3 Interventions
Inhaled nitric oxide (iNO) will be administered via the CPB machine and after CPB via the inspiratory limb of the anesthetic or ventilator circuit, and thereafter via the mechanical ventilator in the ICU. Test gas administration will commence at the onset of CPB and last for 24 hours. At the end of 24 hours, iNO will be weaned and discontinued.
Group II: ControlPlacebo Group2 Interventions
Inhaled nitrogen will be administered via the cardiopulmonary bypass (CPB) machine and after CPB via the inspiratory limb of the anesthetic or ventilator circuit, and thereafter via the mechanical ventilator in the Intensive Care Unit (ICU). Test gas administration will commence at the onset of CPB and last for 24 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitric Oxide
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,927 Previous Clinical Trials
13,198,141 Total Patients Enrolled
1 Trials studying Endothelial Dysfunction
100 Patients Enrolled for Endothelial Dysfunction
Spina, Stefano, M.D., Massachusetts General HospitalUNKNOWN
2 Previous Clinical Trials
350 Total Patients Enrolled
1 Trials studying Endothelial Dysfunction
100 Patients Enrolled for Endothelial Dysfunction
Marrazzo, Francesco, M.D., Massachusetts General HospitalUNKNOWN
2 Previous Clinical Trials
350 Total Patients Enrolled
1 Trials studying Endothelial Dysfunction
100 Patients Enrolled for Endothelial Dysfunction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your systolic blood pressure is less than 90 mmHg, which means your blood pressure is too low.You are not expected to live for more than a year from the time you join the study.You have recently had or are planning to have heart or aortic surgery that requires a heart-lung machine for more than 90 minutes.You have signs of endothelial dysfunction based on answers to a questionnaire.You recently had a heart operation that was not planned.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Nitric Oxide
Awards:
This trial has 1 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are being given the opportunity to participate in this research project?
"That is accurate. The clinicaltrials.gov website has information indicating that this study, which was first made public on December 5th 2018, is still recruiting patients. They need 40 individuals from 2 different locations to participate in the trial."
Answered by AI
Are new participants currently being enrolled in this scientific research?
"Yes, this information is accurate. The study in question was first posted on December 5th, 2018 and updated as recently as November 8th, 2022."
Answered by AI
What are the short- and long-term effects of Nitric Oxide use?
"There is some data supporting Nitric Oxide's safety, but none yet to suggest it is effective. Therefore, it received a score of 2."
Answered by AI
What other areas of research has Nitric Oxide been looked into?
"Currently, 24 different clinical trials are underway for Nitric oxide. Of these 24 active studies, 9 have progressed to Phase 3 testing. These numerous trials originate from a central location in Anchorage, Alaska but are being conducted at 116 sites total."
Answered by AI
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