Effects of Nitric Oxide on the Endothelium During Hemolysis.

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.

Conditions

• Endothelial Dysfunction
• Hemolysis Intravascular
• Cardiovascular Diseases
• Cardiovascular Risk Factor

Interventions

DRUG

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.

DIAGNOSTIC_TEST

Reactive Hyperemia Index

Vascular responsiveness will be assessed with peripheral arterial tonometry which measures the transient increase in forearm blood flow (Reactive Hyperemia Index, RHI) in response to a five-minute occlusion of the brachial artery with a pressure cuff.

PROCEDURE

Endothelial Cells Collection

Endothelial cells are collected before and after surgery from a peripheral vessel using a soft J-shaped wire inserted through an intravascular catheter.

Sponsors & Collaborators

• Spina, Stefano, M.D., Massachusetts General Hospital

  collaborator UNKNOWN

• Marrazzo, Francesco, M.D., Massachusetts General Hospital

  collaborator UNKNOWN

• Zadek, Francesco, M.D., Massachusetts General Hospital

  collaborator UNKNOWN

• Jennifer En-Sian Ho M.D., Massachusetts General Hospital

  collaborator UNKNOWN

• Naomi M Hamburg, M.D., Boston University

  collaborator UNKNOWN

• Massachusetts General Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-05

Primary Completion

2023-11-30

Completion

2023-11-30

FDA Drug

Yes

Countries

• United States

Study Locations