Clinical Trials Logo
  1. Home
  2. Heart Valve Diseases
  3. NCT01802619

Prevention of Renal Failure by Nitric Oxide in Prolonged Cardiopulmonary Bypass.

Heart Valve Diseases Clinical Trial

Official title:
Prevention of Renal Failure by Nitric Oxide in Prolonged Cardiopulmonary Bypass: A Double Blind Randomized Controlled Trial.

Clinical Trial Summary

Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion of nitric oxide (NO) during and after the surgical procedure on CPB may protect against endothelium dysfunction and organ failure caused by plasma-Hb induced NO scavenging.

Clinical Trial Description

Prolonged periods of cardiopulmonary bypass (CPB) cause high levels of plasma free haemoglobin(Hb) and are associated with increased morbidity. We hypothesized that repletion of nitric oxide (NO) during and after the surgical procedure on CPB may protect against endothelium dysfunction and organ failure caused by plasma-Hb induced NO scavenging. There are three possible beneficial mechanisms of delivering NO:

1. Nitric oxide reduces ischemia-reperfusion injury (such as in acute myocardial infarction, stroke, and acute tubular necrosis).

2. Nitric oxide has anti-inflammatory properties. As antioxidants, exogenous NO may reduce injury by counteracting the cytotoxic effects of reactive oxygen species, modulating leukocyte recruitment, edema formation and tissue disruption.

3. Exogenous nitric oxide prevents noxious effects of hemolysis-associated NO dysregulation. During hemolysis, nitric oxide gas oxidized of plasma oxyhemoglobin to methemoglobin, thereby inhibiting endogenous endothelium NO scavenging by cell-free Hb.

NO depletion during hemolysis and its sequelae. The release of plasma free Hb (with Fe2+ iron) by hemolysis avidly scavenges nitric oxide (NO) by the dioxygenation reaction. Elevated plasma ferrous Hb levels can induce a "NO deficiency" state. Reduced vascular nitric oxide levels can contribute to vasoconstriction, inflammation, and thrombosis, potentially contributing to systemic endothelial dysfunction after cardiac surgery with CPB. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01802619
Study type Interventional
Source Xijing Hospital
Contact
Status Completed
Phase Phase 1/Phase 2
Start date August 2013
Completion date June 2016
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02865798 - China Senile Valvular Heart Disease Cohort Study N/A
Completed NCT02249000 - BIOVALVE - I / II Clincial Investigation N/A
Completed NCT02297334 - Removal of Cytokines During Extracorporeal Circulation in Cardiac Surgery N/A
Completed NCT01591018 - SONOlysis in Risk REduction of Symptomatic and Silent Brain infarCtions dUring Cardiac surgEry Phase 3
Completed NCT01428947 - Does Coronary Angiography Cause Cognitive Dysfunction? N/A
Recruiting NCT01231776 - Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass N/A
Terminated NCT01116037 - ATS 3f(r) Aortic Bioprosthesis Model 1000 Post Approval Study N/A
Completed NCT00371891 - Ontario Multidetector Computed Tomographic (MDCT) Coronary Angiography Study (OMCAS) Phase 4
Terminated NCT03632967 - Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System N/A
Recruiting NCT05728047 - Evaluation of Systemic Microcirculation of Patients Undergoing Heart Valve Surgery
Not yet recruiting NCT05539261 - Research on Neurological Prognosis of Patients Undergoing Heart Valve Surgery
Completed NCT05479968 - Spectroscopic Assessment of Intramyocardial Oxygen Saturation Feasibility During Open-heart Surgery
Completed NCT03527381 - Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery Phase 1/Phase 2
Completed NCT03664102 - Automated Fastener Device Versus Manually Tied Knot in MiAVR
Recruiting NCT06084091 - Spectroscopic Assessment of Intramyocardial Oxygen Saturation During Open-Heart Surgery
Completed NCT05836467 - Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?
Recruiting NCT05933083 - MCNAIR Study: coMparative effeCtiveness of iN-person and teleheAlth cardIac Rehabilitation N/A
Recruiting NCT04445012 - Cardiovascular Acoustics and an Intelligent Stethoscope
Active, not recruiting NCT02732691 - JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study N/A
Completed NCT02981953 - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System N/A