NCT03169608

Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery

Predicting Post-surgery Complications in Patients Undergoing Coronary Artery Bypass Graft Through the Assessment of Perioperative Cardiovascular Control Indices

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Characterization of the perioperative autonomic nervous system state, cardiovascular and cerebrovascular control and microcirculation in order to predict postoperative atrial fibrillation and acute kidney injury in patients undergoing coronary artery bypass graft surgery

Detailed description

Atrial fibrillation (AF) and acute kidney injury (AKI) are common postoperative complications in patients undergoing coronary artery bypass graft (CABG) surgery. AKI increases postoperative mortality and AF prolongs the hospital stay. Autonomic dysfunction, baroreflex impairment and an inadequate microvascular perfusion may play a relevant role in triggering AF and AKI. The perioperative characterization of the autonomic nervous system (ANS) and of the microcirculation might improve risk stratification and help in the prevention and early treatment of AF and AKI in CABG surgery. The study aims are: i) to collect a number of perioperative indices describing the state of the ANS and of the microcirculation; ii) to assess the correlation among the different indices and their association with AF and AKI; iii) to develop a predictive model of postoperative outcomes (AF and AKI) accounting for perioperative autonomic indices and microcirculatory variables. Population: 200 adults subjects scheduled for CABG surgery, with or without additional intervention Methods: perioperative (in the operating room) acquisition of ECG, arterial blood pressure, cerebral blood flow velocity as derived from transcranial doppler technique, microcirculation parameters as derived from sidestream dark field images Statistics: receiver operating characteristic (ROC) curve analysis with adequate cut-off values

Conditions

• Atrial Fibrillation
• Acute Kidney Injury

Timeline

• Start date: 2017-04-03
• Primary completion: 2019-07-14
• Completion: 2019-07-14
• First posted: 2017-05-30
• Last updated: 2017-05-30

Locations

1 site across 1 country: Italy