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Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery

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ClinicalTrials.gov Identifier: NCT03169608
Recruitment Status : Unknown
Verified May 2017 by Marco Ranucci, IRCCS Policlinico S. Donato.
Recruitment status was:  Recruiting
First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Marco Ranucci, 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

Condition or disease
Atrial Fibrillation Acute Kidney Injury

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

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Post-surgery Complications in Patients Undergoing Coronary Artery Bypass Graft Through the Assessment of Perioperative Cardiovascular Control Indices
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : July 14, 2019
Estimated Study Completion Date : July 14, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult coronary surgery patients
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169608


Contacts
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Contact: Vlasta Bari, PhD 0039025277 ext 4381 vlasta.bari@grupposandonato.it
Contact: Valeria Pistuddi 0039025277 ext 4754 valeria.pistuddi@grupposandonato.it

Locations
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Italy
IRCCS Policlinico San Donato Recruiting
San Donato Milanese, Milan, Italy, 20097
Contact: Vlasta Bari, PhD    0039025277 ext 4381    vlasta.bari@grupposandonato.it   
Principal Investigator: Marco Ranucci, MD, FESC         
Sub-Investigator: Vlasta Bari, PhD         
Sub-Investigator: Umberto Di Dedda, MD         
Sub-Investigator: Giovanni Ranuzzi, MSc         
Sub-Investigator: Valeria Pistuddi         
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
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Principal Investigator: Marco Ranucci, MD, FESC IRCCS Policlinico San Donato
Publications:

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Responsible Party: Marco Ranucci, Director of Cardiothoracic Anesthesia and ICU Dept, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT03169608    
Other Study ID Numbers: GR2013
GR-2013-02356272 ( Other Grant/Funding Number: Italian Ministery of Health )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marco Ranucci, IRCCS Policlinico S. Donato:
autonomic nervous system
atrial fibrillation
acute kidney injury
baroreflex sensitivity
microcirculation
coronary artery bypass graft
Additional relevant MeSH terms:
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Acute Kidney Injury
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases