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Vasodilator

Nitric Oxide for Acute Kidney Injury (MGHK23 Trial)

Phase 3
Waitlist Available
Led By Lorenzo Berra, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Elective cardiac or aortic surgery with CPB>90 minutes
Clinical evidence of endothelial dysfunction assessed by a specifically designed questionnaire
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours and 1 year follow up
Awards & highlights

MGHK23 Trial Summary

This trial will test whether nitric oxide, given through a mask, can improve outcomes for patients with kidney injury undergoing cardiac surgery.

MGHK23 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have recently undergone a planned heart or aorta surgery that lasted more than 90 minutes with the use of a heart-lung machine.
Select...
You have signs of blood vessel problems as shown by a special questionnaire.

MGHK23 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute kidney injury
Secondary outcome measures
AKI severity
Duration of mechanical ventilation
Hospital length of stay (LOS)
+6 more
Other outcome measures
Cardiac and non-cardiac complications
Incidence of AKI related to risk factors
Incidence of delirium
+9 more

MGHK23 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nitric OxideExperimental Treatment1 Intervention
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. Once patients are extubated they will breathe test gas via a facemask or nasal cannula. 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 while carefully monitoring hemodynamics for a period of 2-4 hours.
Group II: ControlPlacebo Group1 Intervention
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). Once patients are extubated they will breathe test gas via a facemask or nasal cannula. 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
2004
Completed Phase 4
~1280

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,718 Total Patients Enrolled
3 Trials studying Acute Kidney Injury
104,324 Patients Enrolled for Acute Kidney Injury
Ichinose, Fumito, M.D., Ph.D., Massachusetts General HospitalUNKNOWN
Kenneth, Shelton, M.D., Massachusetts General HospitalUNKNOWN

Media Library

Nitric Oxide (Vasodilator) Clinical Trial Eligibility Overview. Trial Name: NCT02836899 — Phase 3
Acute Kidney Injury Research Study Groups: Control, Nitric Oxide
Acute Kidney Injury Clinical Trial 2023: Nitric Oxide Highlights & Side Effects. Trial Name: NCT02836899 — Phase 3
Nitric Oxide (Vasodilator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02836899 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the possible negative side effects of Nitric Oxide?

"There is pre-existing clinical evidence to support Nitric Oxide's safety, thus it was given a score of 3."

Answered by AI

What is the size of the test group for this research?

"This particular study is no longer recruiting patients. The trial was initially posted on February 8th, 2017 and was last edited on November 8th, 2022. There are presently 131 clinical trials actively searching for patients with acute kidney injury and 24 trials for Nitric Oxide actively recruiting participants."

Answered by AI

Does a body of research exist for Nitric Oxide's therapeutic effect?

"There are 24 ongoing clinical trials researching the efficacy of nitric oxide. 9 of these studies have progressed to Phase 3 testing. Although many of the investigations are based in Anchorage, Alaska, there are 116 locations across the world running similar trials."

Answered by AI

Are new participants being sought for this research project?

"This study is not enrolling patients at the moment, however this could change in the future. The trial was originally posted on 2/8/2017 and was last updated on 11/8/2022. For those interested, there are presently 131 trials actively admitting patients with acute kidney injury and 24 studies for Nitric Oxide actively enrolling patients."

Answered by AI
~31 spots leftby Mar 2025