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Clinical Trials/NCT03169608
NCT03169608
Unknown
Not Applicable

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

IRCCS Policlinico S. Donato1 site in 1 country200 target enrollmentApril 3, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
IRCCS Policlinico S. Donato
Enrollment
200
Locations
1
Primary Endpoint
Atrial Fibrillation
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
April 3, 2017
End Date
July 14, 2019
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
IRCCS Policlinico S. Donato
Responsible Party
Principal Investigator
Principal Investigator

Marco Ranucci

Director of Cardiothoracic Anesthesia and ICU Dept

IRCCS Policlinico S. Donato

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Atrial Fibrillation

Time Frame: 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

Time Frame: 48 hours from surgery

50% increase of serum creatinine with respect to baseline or absolute increase \> 0.3 mg/ml

Study Sites (1)

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