Effects of Nitric Oxide on the Endothelium During Hemolysis.
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.
Conditions:
🦠 Endothelial Dysfunction 🦠 Hemolysis Intravascular 🦠 Cardiovascular Diseases 🦠 Cardiovascular Risk Factor
🗓️ Study Start (Actual) 5 December 2018
🗓️ Primary Completion (Estimated) November 2023
✅ Study Completion (Estimated) November 2023
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Boston, Massachusetts, United States
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 November 2018
  • First Submitted that Met QC Criteria 16 November 2018
  • First Posted 20 November 2018

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 November 2022
  • Last Update Posted 10 November 2022
  • Last Verified November 2022