Overview

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