Effects of Nitric Oxide on Vascular Responsiveness and on Endothelial Cells During Hemolysis in Patients With Pre-operative Endothelial Dysfunction Undergoing Prolonged Cardiopulmonary Bypass.

Who is this study for? Patients with pre-operative endothelial dysfunction undergoing cardiac surgery requiring prolonged cardiopulmonary bypass
Status: Withdrawn
Location: See all (2) locations...
Intervention Type: Diagnostic test, Procedure, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Medical Center
Boston
Massachusetts General Hospital
Boston
Time Frame
Start Date: 2018-12-05
Completion Date: 2023-11
Treatments
Placebo_comparator: Control
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). Test gas administration will commence at the onset of CPB and last for 24 hours.
Experimental: Nitric Oxide
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. 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.
Related Therapeutic Areas
Sponsors
Collaborators: Spina, Stefano, M.D., Massachusetts General Hospital, Zadek, Francesco, M.D., Massachusetts General Hospital, Marrazzo, Francesco, M.D., Massachusetts General Hospital, Naomi M Hamburg, M.D., Boston University, Jennifer En-Sian Ho M.D., Massachusetts General Hospital
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov