Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.
NCT02836899 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2026-03-10
Summary
The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing prolonged cardiopulmonary bypass.
Conditions
Interventions
- DRUG
-
Nitric Oxide
Inhaled nitric oxide will be administered in a final concentration of 80 ppm. The treatment will begin at the onset of the cardiopulmonary bypass until to 24h after Intensive Care Unit (ICU) admission, including 2-4 hours of weaning from nitric oxide and careful hemodynamics monitoring.
- OTHER
-
Placebo
This is the placebo group. Nitrogen will be added instead of nitric oxide.
Sponsors & Collaborators
-
Ichinose, Fumito, M.D., Ph.D., Massachusetts General Hospital
collaborator UNKNOWN -
Kenneth, Shelton, M.D., Massachusetts General Hospital
collaborator UNKNOWN -
Kacmarek, Robert M., Ph.D., Massachusetts General Hospital
collaborator UNKNOWN -
Sundt, Thoralf M., M.D., Massachusetts General Hospital
collaborator UNKNOWN -
Villavicencio-Theoduloz, Mauricio A., M.D., Massachusetts General Hospital
collaborator UNKNOWN -
Thompson, Boyd Taylor, M.D., Massachusetts General Hospital
collaborator UNKNOWN -
Bonventre, Joseph V., M.D., Brigham Women Hospital
collaborator UNKNOWN -
Shann, Kenneth G., Massachusetts General Hospital
collaborator UNKNOWN -
Zapol, Warren M., M.D.
collaborator INDIV -
Marrazzo, Francesco, M.D., Massachusetts General Hospital
collaborator UNKNOWN -
Spina, Stefano, M.D., Massachusetts General Hospital
collaborator UNKNOWN -
Zadek, Francesco, M.D., Massachusetts General Hospital
collaborator UNKNOWN -
Rezoagli, Emanuele, M.D., Massachusetts General Hospital
collaborator UNKNOWN -
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Lorenzo Berra, MD · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-08
- Primary Completion
- 2025-08-15
- Completion
- 2025-08-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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