Status:
WITHDRAWN
Effects of Prolonged Delivery of Nitric Oxide Gas on Plasma Reduction-Oxidation Reactions in Cardiac Surgical Patients
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Zadek, Francesco, M.D., Massachusetts General Hospital
Spina, Stefano, M.D., Massachusetts General Hospital
Conditions:
Cardiovascular Diseases
Oxidative Stress
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 NCT...
Detailed Description
The endothelial dysfunction is a pathologic process characterized by impaired endothelial nitric oxide (NO) signaling and metabolism leading to decreased vascular response to vasodilation. Cardiac sur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04022161
Start Date
July 25 2019
End Date
November 24 2025
Last Update
December 2 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
MP 825 Southampton General Hospita
Southampton, Hampshire, United Kingdom, SO16 6YD