Clinical Trials Logo
  1. Home
  2. Cardiopulmonary Bypass
  3. NCT01002859

Effect of Preliminary Administration of Cyclosporine (Sandimmun ®) on Different Markers of Cardiac Ischaemia Induced by Cardiopulmonary Bypass — Ciclo et CEC  

Cardiopulmonary Bypass Clinical Trial

Official title:
Double-Blind Phase II Pilot Monocentric Randomized Clinical Trial Evaluating the Effect of a Preliminary Administration of Cyclosporine on Different Markers of Cardiac Ischemia Led by the Aortic Cross-clamp During Coronary Artery Bypass Surgery With Cardiopulmonary Bypass.

Clinical Trial Summary

Observe the effect of preliminary cyclosporine administration on different markers of cardiac ischaemia led by the aortic cross-clamp during coronary artery bypass surgery with Cardiopulmonary bypass.

Clinical Trial Description

The coronary artery bypass surgery, in spite of substantial improvements during the last years, is still associated to a post-operative mortality and morbidity: myocardial infarction, heart failure, cardiac arrhythmia, renal failure, Stroke.

These complications are often due to ischaemia - reperfusion injury event. Recent studies showed that in case of cellular stress (in particular during the reperfusion after ischaemia) a not specific pore, called Mitochondrial permeability transition Pore (MPTP), could be opened. That caused the loss of ion homeostasis, then cell death as well as by apoptosis as by necrosis.

Prevent the opening of this MPTP during the myocardial reperfusion after coronary bypass, for example, is an important objective to improve the cardioprotection.

The Cyclosporin A, prevents the MPTP from opening. Several studies have shown an cytoprotection led by cyclosporin A, after ischaemia reperfusion in several models as isolated rats heart, in vivo rats heart and ex vivo myocardial ( atrial ) human tissues.

Recently, a multicentric study performed in humans, during the acute phase of myocardial infarction, showed a reduction of infarct size by approximately 40% in the cyclosporine group compared to control group. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01002859
Study type Interventional
Source University Hospital, Grenoble
Contact
Status Terminated
Phase Phase 2
Start date April 2009
Completion date July 2011
View Details
See also
  Status Clinical Trial Phase
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT04062396 - Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction N/A
Completed NCT02518087 - Increased Adsorption Membranes During Cardiopulmonary Bypass N/A
Recruiting NCT01231776 - Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass N/A
Completed NCT00747331 - Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass Phase 4
Terminated NCT00176657 - The Use of HEMOBAG to Salvage Blood After Cardiac Surgery Phase 2
Completed NCT00161733 - Safety and Hemostatic Efficacy of Fibrin Sealant Vapor Heated, Solvent/Detergent Treated (FS VH S/D) Compared With Currently Licensed TISSEEL VH Fibrin Sealant in Subjects Undergoing Cardiac Surgery Phase 3
Completed NCT05525195 - Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery
Completed NCT05537168 - Bayesian Networks in Pediatric Cardiac Surgery
Completed NCT04238806 - Desflurane,Brain Natriuretic Peptide and Cardiac Surgery N/A
Completed NCT00981474 - Cerebral Autoregulation Monitoring During Cardiac Surgery N/A
Recruiting NCT05588011 - Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass N/A
Completed NCT02566733 - Minto Model in Effect Site Mode for Target-Controlled Infusion of Remifentanil During Cardiopulmonary Bypass Phase 4
Terminated NCT00385450 - Cardiopulmonary Bypass-Induced Lymphocytopenia and the Potential Effects of Protease Inhibitor Phase 1
Completed NCT00246740 - Protection of the Heart With Doxycycline During Coronary Artery Bypass Grafting Phase 2
Not yet recruiting NCT05075265 - Pharmacokinetics of Methadone in Adults Undergoing Cardiac Surgery With Extracorporeal Circulation
Recruiting NCT04296071 - Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)
Completed NCT05579964 - The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot Phase 2/Phase 3
Active, not recruiting NCT04133740 - Oxygenation Targets in Cardiac Surgery Patients - a Before-and-after Study Phase 4
Completed NCT05033236 - Platelets and Complement Activation in Coronary Artery Bypass Graft Surgery (CABG)