Clinical Trials Logo

Clinical Trial Summary

The investigators designed the randomized prospective study to evaluate the differences of inflammatory response and clinical outcome after on-pump beating coronary artery bypass grafting undergoing left ventricular assist versus biventricular assist in patients with severe left ventricle dysfunction.


Clinical Trial Description

Off-pump coronary artery bypass grafting (CABG) tends to have a lower incidence of postoperative complications and remarkable advantages in terms of hospital stay. However, some drawbacks include higher rates of incomplete revascularization and the hemodynamic deterioration during manipulation of the heart, more occurring in the cases of posterolateral anatomical constraints and cardiac dysfunction. It leads to urgent conversion to extracorporeal circulation (ECC) and increases the mortality. Although conventional ECC with cardioplegia arrest provides bloodless immovable field, intense systemic inflammatory response may contribute to hemodynamic unstability especially in patients already with severe cardiac dysfunction. On-pump beating CABG, as a more comprehensive approach, not only facilitates stable hemodynamics and complete revascularization, but also supports myocardial lymphatic flow balance and decreases interstitial myocardial edema in the beating state. Especially in the high-risk patients,some findings suggested that off-pump CABG should be converted to on-pump beating CABG without hesitation, avoiding hemodynamic collapse and even catastrophic outcomes. Some investigators intentionally planned on-pump beating CABG aiming to some patients with severe left ventricle dysfunction. Furthermore, on-pump beating CABG with ECC assistance in a high-risk subgroup is also an acceptable trade-off between conventional cardioplegia and off-pump operations. The above-mentioned ECC results about on-pump, beating-heart CABG pay much attention to the biventricular assist (BiVA). Nonetheless, much evidence also reveals that BiVA triggers an intense inflammatory response due to extracorporeal membrane lung and circuit line. Comparatively speaking, single left ventricular assist (LVA), with shorter circuit line, less priming volume and free of extracorporeal membrane lung, theoretically should reduce the inflammatory response and relative complications. As a result, aiming to the high-risk patients with severe left ventricle dysfunction, who need ECC assistance (BiVA or LVA), the investigators designed the randomized prospective study to evaluate: 1) the differences in myocardial injury as expressed by cardiac Troponin I(cTnI) and in inflammatory response by C-reactive protein (CRP), 2) the differences in the early postoperative outcomes including graft number, incidence of atrial fibrillation, in-hospital mortality and ICU stay. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02731794
Study type Interventional
Source Henan Institute of Cardiovascular Epidemiology
Contact
Status Active, not recruiting
Phase Phase 4
Start date May 2016
Completion date October 2023

See also
  Status Clinical Trial Phase
Recruiting NCT03235323 - Efficacy of External CounterPulsation for Postoperative Coronary Artery Bypass Grafting Patients N/A
Completed NCT05036044 - Stroke and Carotid-Cerebral Vascular Disease After CABG
Recruiting NCT05010460 - Study of Roxadustat for Reducing the Incidence of Acute Kidney Injury After Coronary Artery Bypass Grafting Phase 2
Completed NCT03622671 - Fibrin Clot Properties and Blood Loss Following Coronary Artery By-pass Grafting N/A
Completed NCT00400790 - Organ Protection for Coronary Artery Bypass Graft (CABG): Propofol Versus Desflurane N/A
Not yet recruiting NCT03275220 - Assessment Of Right Ventricular Function In Patients Undergoing Coronary Artery Bypass Graft In Assiut University N/A
Completed NCT01256372 - An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery Phase 2
Completed NCT00489827 - Glutamate for Metabolic Intervention in Coronary Surgery Phase 3
Completed NCT04591119 - Transversus Thoracis Muscle Plane Block for Postoperative Pain in Adult Cardiac Surgery N/A
Active, not recruiting NCT03908593 - Proton Pump Inhibitor Preventing Upper Gastrointestinal Injury In Patients On Dual Antiplatelet Therapy After CABG Phase 4
Recruiting NCT03774342 - The Influence of Cognitive Decline on Quality of Life After Coronary Bypass
Enrolling by invitation NCT03999398 - Short and Long-term Results of PCI in no Touch Vein-graft.
Recruiting NCT05414331 - WithDRawal Impact Of Postoperative Beta-Blocker N/A
Completed NCT02981680 - Effect of Remote Ischemic Preconditioning on the Incidence of Acute Kidney Injury in Patients Undergoing Coronary Artery Bypass Graft Surgery N/A
Completed NCT00600704 - Impact of Fluid Restriction Policy in Reducing the Use of Red Cells in Cardiac Surgery N/A
Completed NCT06013605 - Effect of Walking Exercise on Functional Capacity and Productivity in Patients After Coronary Artery Bypass Graft N/A
Completed NCT02722213 - Mindfulness & Stress Management Study for Cardiac Patients N/A
Completed NCT01285271 - A Pre- and Post- Coronary Artery Bypass Graft Implantation Disposed Application of Xenon Phase 3
Completed NCT00823082 - Use of Antithrombin in Cardiac Surgery With Cardiopulmonary Bypass Phase 2
Completed NCT00911976 - Study of the Xience V Everolimus-eluting Stent in Saphenous Vein Graft Lesions Phase 4