Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery

May 26, 2017 updated by: Marco Ranucci, IRCCS Policlinico S. Donato

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

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

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • San Donato Milanese, Milan, Italy, 20097
        • Recruiting
        • IRCCS Policlinico San Donato
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult coronary surgery patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from the admission to the ICU to the hospital discharge, with an average of 8 days
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
48 hours from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Policlinico S. Donato

Investigators

  • Principal Investigator: Marco Ranucci, MD, FESC, IRCCS Policlinico San Donato

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2017

Primary Completion (Anticipated)

July 14, 2019

Study Completion (Anticipated)

July 14, 2019

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 26, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR2013
  • GR-2013-02356272 (Other Grant/Funding Number: Italian Ministery of Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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