Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery

• Conditions: Acute Kidney Injury; Atrial Fibrillation

• Registration Number: NCT03169608
• Lead Sponsor: IRCCS Policlinico S. Donato

Brief 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

Study Timeline

• Study Start: 2017-04-03
• Status Verified: 2017-05
• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-26
• Last Update Submitted: 2017-05-26
• Study First Posted: 2017-05-30
• Last Update Posted: 2017-05-30
• Primary Completion: 2019-07-14
• Study Completion: 2019-07-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• age over 18
• sinus rhythm
• absence of pathologies affecting autonomic nervous system (e.g. diabetes with neuropathy)
• informed consent signed
• elective or urgent surgery

Exclusion Criteria

• age under 18
• absence of sinus rhythm
• pathologies affecting autonomic nervous system
• emergency surgery (to be operated immediately)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation	from the admission to the ICU to the hospital discharge, with an average of 8 days	any atrial fibrillation event recorded during the postoperative period, as derived from ECG monitoring
Acute Kidney Injury	48 hours from surgery	50% increase of serum creatinine with respect to baseline or absolute increase \> 0.3 mg/ml

Trial Locations

Locations (1)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milan, Italy