Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03169608
• Other study ID #: GR2013
• Secondary ID: GR-2013-02356272
• Status: Recruiting
• Phase: N/A
• First received: May 24, 2017
• Last updated: May 26, 2017
• Start date: April 3, 2017
• Est. completion date: July 14, 2019

Study information

• Verified date: May 2017
• Source: IRCCS Policlinico S. Donato
• Contact: Vlasta Bari, PhD
• Phone: 0039025277
• Email: vlasta.bari[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 14, 2019
• Est. primary completion date: July 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Atrial Fibrillation

Locations

Country	Name	City	State
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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. — View Citation

Ince C. The microcirculation is the motor of sepsis. Crit Care. 2005;9 Suppl 4:S13-9. Epub 2005 Aug 25. Review. — View Citation

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. — View Citation

Provenchère S, Plantefève 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):1258-64, table of contents. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Acute Kidney Injury	50% increase of serum creatinine with respect to baseline or absolute increase > 0.3 mg/ml	48 hours from surgery