Atrial FibrillationNCT03169608
Autonomic State, Cardiovascular Control and Outcomes in Coronary Surgery
An observational study of Atrial Fibrillation and Acute Kidney Injury, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Acute Kidney Injury
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2017to 14 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult coronary surgery patients
Who may be able to join
- age over 18
- sinus rhythm
- absence of pathologies affecting autonomic nervous system (e.g. diabetes with neuropathy)
- informed consent signed
- elective or urgent surgery
Who cannot join
- age under 18
- absence of sinus rhythm
- pathologies affecting autonomic nervous system
- emergency surgery (to be operated immediately)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico San Donato
San Donato Milanese, Milan, 20097
Vlasta Bari, PhD, 0039025277 ext. 4381, vlasta.bari@grupposandonato.it
Marco Ranucci, MD, FESC
About this study
Official title: 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
Read the 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
- Conditions
- Atrial Fibrillation, Acute Kidney Injury
- Keywords
- autonomic nervous system, atrial fibrillation, acute kidney injury, baroreflex sensitivity, microcirculation, coronary artery bypass graft
- Medical subject headings
- Atrial Fibrillation, Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial Fibrillation
any atrial fibrillation event recorded during the postoperative period, as derived from ECG monitoring
Measured: 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
Measured: 48 hours from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start3 Apr 2017
- Primary completion14 Jul 2019 (estimated)
- Study completion14 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Ranucci, IRCCS Policlinico S. Donato
- Investigators
- Marco Ranucci, MD, FESC, Principal investigator, IRCCS Policlinico S. Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169608
- Sponsor's protocol ID
- GR2013
- Other IDs
- GR-2013-02356272
- Status last verified
- May 2017
- First submitted
- 24 May 2017
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14998610Provenchere 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.
PubMed 12707117Heart 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.
PubMed 8598068Pagani 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.
PubMed 9118511Faes 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.
PubMed 23541295Ince 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.
PubMed 16168069Singh 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.
PubMed 40186491
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Post-surgery Complications in Patients Undergoing Coronary Artery Bypass Graft Through the Assessment of Perioperative Cardiovascular Control Indices
- ClinicalTrials.gov ID
- NCT03169608
- Acronym / sponsor ID
- GR2013
- Conditions
- Atrial Fibrillation, Acute Kidney Injury
- Keywords
- autonomic nervous system, atrial fibrillation, acute kidney injury, baroreflex sensitivity, microcirculation, coronary artery bypass graft
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 14 Jul 2019 (estimated)
- Study completion
- 14 Jul 2019 (estimated)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult coronary surgery patients
Key inclusion criteria (5 listed)
- age over 18
- sinus rhythm
- absence of pathologies affecting autonomic nervous system (e.g. diabetes with neuropathy)
- informed consent signed
- elective or urgent surgery
Key exclusion criteria (4 listed)
- age under 18
- absence of sinus rhythm
- pathologies affecting autonomic nervous system
- emergency surgery (to be operated immediately)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Background: PubMed 14998610Villareal 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.
- Background: PubMed 12707117Provenchere 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.
- Background: PubMed 8598068Heart 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.
- Background: PubMed 9118511Pagani 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.
- Background: PubMed 23541295Faes 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.
- Background: PubMed 16168069Ince 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.
- Derived from this study: PubMed 40186491Singh 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.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Ranucci, MD, FESC principal investigator
IRCCS Policlinico S. Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Acute Kidney Injury, run by IRCCS Policlinico S. Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vlasta Bari, PhD (0039025277 ext. 4381, vlasta.bari@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation (time frame: from the admission to the ICU to the hospital discharge, with an average of 8 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03169608, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.