Effects of Prolonged Delivery of Nitric Oxide Gas on Plasma Reduction-Oxidation Reactions in Cardiac Surgical Patients

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 plasma reduction-oxidation reactions of patients undergoing cardiac surgery requiring prolonged cardiopulmonary bypass.

Conditions

• Cardiovascular Diseases
• Oxidative Stress
• Endothelial Dysfunction

Interventions

DRUG

Nitrogen Gas for Inhalation

See arm description

OTHER

Blood withdrawal

Blood samples will be collected over four time-points: (I) baseline (before surgery) (II) end of the surgery, (III) end of 24 hours of gas delivery and (IV) 24 hours from the gas suspension.

DRUG

Nitric Oxide

See arm description

Sponsors & Collaborators

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

  collaborator UNKNOWN

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

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• University of Southampton

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Lorenzo Berra, MD · Massachusett General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-25

Primary Completion

2025-11-24

Completion

2025-11-24

FDA Drug

Yes

Countries

• United States
• United Kingdom

Study Locations