Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Bonventre, Joseph V., M.D., Brigham Women Hospital; Fisher, Daniel, R.R.T., Massachusetts General Hospital; Ichinose, Fumito, M.D., Ph.D., Massachusetts General Hospital; Kacmarek, Robert M., Ph.D., Massachusetts General Hospital; Kenneth, Shelton, M.D., Massachusetts General Hospital; Marrazzo, Francesco, M.D., Massachusetts General Hospital; National Heart, Lung, and Blood Institute (NHLBI); Rezoagli, Emanuele, M.D., Massachusetts General Hospital; Roy, Nathalie, M.D., Massachusetts General Hospital; Shann, Kenneth G., Massachusetts General Hospital; Spina, Stefano, M.D., Massachusetts General Hospital; Sundt, Thoralf M., M.D., Massachusetts General Hospital; Thompson, Boyd Taylor, M.D., Massachusetts General Hospital; Villavicencio-Theoduloz, Mauricio A., M.D., Massachusetts General Hospital; Zadek, Francesco, M.D., Massachusetts General Hospital; Zapol, Warren M., M.D.
• Treatments: Nitric Oxide

Criteria

Inclusion Criteria:

1. Provide written informed consent

2. Age ≥ 18 years of age

3. Elective cardiac or aortic surgery with CPB>90 minutes

4. Stable pre-operative renal function without evidence of plasma creatinine level increase of ≥ 0.3 mg/dL over the prior 3 months and without renal replacement therapy (RRT).

5. Clinical evidence of endothelial dysfunction assessed by a specifically designed questionnaire.

Exclusion Criteria:

1. eGFR less than 30 ml/min/1.73 m2

2. Emergent cardiac surgery.

3. Life expectancy < 1 year at the time of enrollment.

4. Hemodynamic instability as defined by a systolic blood pressure <90 mmHg.

5. Mean pulmonary artery pressure ≥ 40 mm Hg and PVR > 4 Wood Units.

6. Left ventricular ejection fraction < 30% by echocardiography obtained within three months of enrollment

7. Administration of one or more Packed Red Blood Cells (RBCs) transfusion in the week prior to enrollment.

8. X-ray contrast infusion less than 48 hours before surgery.

9. Evidence of intravascular or extravascular hemolysis from any other origin:

i. Intravascular: Intrinsic RBCs defects leading to hemolytic anemia (eg, enzyme deficiencies, hemoglobinopathies, membrane defects). Extrinsic: liver disease, hypersplenism, infections (eg, bartonella, babesia, malaria), treatment with oxidizing exogenous agents (eg, dapsone, nitrites, aniline dyes), exposure to other hemolytic agents (eg, lead, snake and spider bites), lymphocyte leukemia, autoimmune hemolytic disorders.

ii. Extravascular: Infection (eg, clostridial sepsis, severe malaria), paroxysmal cold hemoglobinuria, cold agglutinin disease, paroxysmal nocturnal hemoglobinuria, iv infusion of Rho(D) immune globulin, iv infusion of hypotonic solutions.