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Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery

S

San Donato Group (GSD)

Status

Unknown

Conditions

Atrial Fibrillation
Acute Kidney Injury

Study type

Observational

Funder types

Other

Identifiers

NCT03169608
GR-2013-02356272 (Other Grant/Funding Number)
GR2013

Details and patient eligibility

About

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

Full 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

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Central trial contact

Vlasta Bari, PhD; Valeria Pistuddi

Data sourced from clinicaltrials.gov

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