Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-24 @ 1:10 PM
NCT ID:
NCT04022161
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 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.
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 surgical patients affected by multiple cardiovascular risk factors (e.g., hypertension, diabetes, dyslipidemia) commonly present with endothelial dysfunction due to a chronic unbalance of the redox state caused by an increased oxidative stress. Moreover, the use of cardiopulmonary bypass, the hemolysis, the ischemia and the inflammation associated with the surgery magnifies the oxidative stress, which has been shown to contribute to post-operative complications. In order to decrease oxidative stress, several antioxidant drugs and vitamins have been trialed with marginal health benefits.
Recently, different research groups reported that NO delivered during cardiac surgery improved outcomes both in children and adults. Nitric oxide decreased the incidence and the severity of postoperative acute kidney injury, the extension of infarction size, the duration of mechanical ventilation, the length of stay and the use of rescue therapies as postoperative venous-arterial extra-corporeal membrane oxygenation.
The exogenous administration of NO has been shown to prevent the scavenging of endogenous NO by inactivating the highly oxidative-reactive ferrous plasma oxy-hemoglobin to ferric met-hemoglobin. Our group is conducting a randomized controlled trial at Massachusetts General Hospital (Boston, USA) in patients with signs and symptoms of endothelial dysfunction, undergoing cardiac surgery requiring prolonged cardiopulmonary bypass and randomized to receive NO or placebo. However, the mechanisms underlying the effects of NO admistration on plasmatic redox equilibrium have still to be determined. The aim of this ancillary study is (I) to determine the changes of redox state in the plasma of surgical patients receiving either 80 ppm of NO (study group) or Nitrogen (placebo group). (II) To evaluate whether the degree of change in redox state is associated to postoperative complication.
Study:
NCT04022161
Study Brief:
Protocol Section:
NCT04022161