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
|Condition or disease|
|Atrial Fibrillation Acute Kidney Injury|
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|
|Estimated Enrollment :||200 participants|
|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|
- 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
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
|Contact: Vlasta Bari, PhD||0039025277 ext firstname.lastname@example.org|
|Contact: Valeria Pistuddi||0039025277 ext email@example.com|
|IRCCS Policlinico San Donato||Recruiting|
|San Donato Milanese, Milan, Italy, 20097|
|Contact: Vlasta Bari, PhD 0039025277 ext 4381 firstname.lastname@example.org|
|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|
|Principal Investigator:||Marco Ranucci, MD, FESC||IRCCS Policlinico San Donato|