Effects of Nitric Oxide on the Endothelium During Hemolysis.

• Status: Recruiting
• Trial end date: 2022-10-30
• Target enrollment: 0
• Participant gender: All

Summary

This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery.

This ancillary study aims to assess the effects of Nitric Oxide on vascular responsiveness and on endothelial function during hemolysis in patients with pre-operative endothelial dysfunction undergoing cardiac surgery requiring prolonged cardiopulmonary bypass.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborators: Jennifer En-Sian Ho M.D., Massachusetts General Hospital; Marrazzo, Francesco, M.D., Massachusetts General Hospital; Naomi M Hamburg, M.D., Boston University; Spina, Stefano, M.D., Massachusetts General Hospital; Zadek, Francesco, M.D., Massachusetts General Hospital
• Treatments: Anesthetics; Nitric Oxide

Criteria

Inclusion Criteria:

• Eligible and randomized in the trial NCT02836899

• Provide written informed consent

• Age ≥ 18 years of age

• Elective cardiac or aortic surgery with CPB >90 minutes

• Clinical evidence of endothelial dysfunction assessed by a specifically designed questionnaire

Exclusion Criteria:

• Estimated Glomerular Filtration Rate 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 Cell (PRBC) transfusions in the week prior to enrollment

• X-ray contrast infusion less than 48 hours before surgery

• Evidence of hemolysis from any other origin:

a. Intravascular: i. Intrinsic RBC defects leading to hemolytic anemia (eg, enzyme deficiencies, hemoglobinopathies, membrane defects) ii. 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 b. 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