Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction. (MGHK23)
Acute Kidney Injury
About this trial
This is an interventional prevention trial for Acute Kidney Injury focused on measuring acute kidney injury; nitric oxide; cardiopulmonary bypass; endothelial dysfunction; cardiac surgery
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Control
Nitric Oxide
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.
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.