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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Kidney Injury

In brief

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.

Key facts

Study ID

NCT02836899

Run by

Massachusetts General Hospital

People needed

250

Starts

2017-02-08

Expected to finish

2025-08-15

Last updated by the study team

2026-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent
• Age ≥ 18 years of age
• Elective cardiac or aortic surgery with CPB>90 minutes
• 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).
• Clinical evidence of endothelial dysfunction assessed by a specifically designed questionnaire.

You may not qualify if…

• eGFR less than 30 ml/min/1.73 m2
• Emergent cardiac surgery.
• Life expectancy < 1 year at the time of enrollment.
• Hemodynamic instability as defined by a systolic blood pressure <90 mmHg.
• Mean pulmonary artery pressure ≥ 40 mm Hg and PVR > 4 Wood Units.
• Left ventricular ejection fraction < 30% by echocardiography obtained within three months of enrollment
• Administration of one or more Packed Red Blood Cells (RBCs) transfusion in the week prior to enrollment.
• X-ray contrast infusion less than 48 hours before surgery.
• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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