Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery

NCT03169608 | Unknown

• 2 other identifiers: GR2013GR-2013-02356272
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation; Acute Kidney Injury

Keywords

autonomic nervous system; atrial fibrillation; acute kidney injury; baroreflex sensitivity; microcirculation; coronary artery bypass graft

Outcome Measures

Primary Outcomes (2)

• Atrial Fibrillation

  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

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

  48 hours from surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult coronary surgery patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

Related Publications (7)

• Villareal RP, Hariharan R, Liu BC, Kar B, Lee VV, Elayda M, Lopez JA, Rasekh A, Wilson JM, Massumi A. Postoperative atrial fibrillation and mortality after coronary artery bypass surgery. J Am Coll Cardiol. 2004 Mar 3;43(5):742-8. doi: 10.1016/j.jacc.2003.11.023.

  PMID: 14998610 BACKGROUND

• Provenchere S, Plantefeve G, Hufnagel G, Vicaut E, de Vaumas C, Lecharny JB, Depoix JP, Vrtovsnik F, Desmonts JM, Philip I. Renal dysfunction after cardiac surgery with normothermic cardiopulmonary bypass: incidence, risk factors, and effect on clinical outcome. Anesth Analg. 2003 May;96(5):1258-1264. doi: 10.1213/01.ANE.0000055803.92191.69.

  PMID: 12707117 BACKGROUND

• Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. No abstract available.

  PMID: 8598068 BACKGROUND

• Pagani M, Montano N, Porta A, Malliani A, Abboud FM, Birkett C, Somers VK. Relationship between spectral components of cardiovascular variabilities and direct measures of muscle sympathetic nerve activity in humans. Circulation. 1997 Mar 18;95(6):1441-8. doi: 10.1161/01.cir.95.6.1441.

  PMID: 9118511 BACKGROUND

• Faes L, Porta A, Rossato G, Adami A, Tonon D, Corica A, Nollo G. Investigating the mechanisms of cardiovascular and cerebrovascular regulation in orthostatic syncope through an information decomposition strategy. Auton Neurosci. 2013 Nov;178(1-2):76-82. doi: 10.1016/j.autneu.2013.02.013. Epub 2013 Mar 27.

  PMID: 23541295 BACKGROUND

• Ince C. The microcirculation is the motor of sepsis. Crit Care. 2005;9 Suppl 4(Suppl 4):S13-9. doi: 10.1186/cc3753. Epub 2005 Aug 25.

  PMID: 16168069 BACKGROUND

• Singh P, Porta A, Ranucci M, Cairo B, Gelpi F, Caruso R, Magon A, Baroni I, Conte G, Bari V. Identifying and preliminary validating patient clusters in coronary artery bypass grafting: integrating autonomic function with clinical and demographic data for personalized care. Eur J Cardiovasc Nurs. 2025 Sep 5;24(6):898-910. doi: 10.1093/eurjcn/zvaf059.

  PMID: 40186491 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marco Ranucci, MD, FESC

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vlasta Bari, PhD

CONTACT

0039025277; vlasta.bari@grupposandonato.it

Valeria Pistuddi

CONTACT

0039025277; valeria.pistuddi@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiothoracic Anesthesia and ICU Dept

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: April 3, 2017
• Primary Completion: July 14, 2019
• Study Completion: July 14, 2019
• Last Updated: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)