Clinical trial NCT03188341: Cardiac Complication After Vascular Surgery
Official title: The Reasons of Repolarization Disturbances Disclosure in Vascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm, Abdominal
Ventricular Arrythmia
Peripheral Arterial Disease
Cardiac Complication
Keywords: vascular surgery
repolarization disturbances
cardiac complications
high risk patient
high risk procedure
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The study was conducted by the team from Department of Anaesthesiology, Intensive Care and Acute Poisoning of the tertiary teaching hospital at the Pomeranian Medical University in Szczecin, Poland.

Brief summary: The vascular surgery is a highest risk procedure when considering postoperative complications associated with the cardiovascular system. The leading clinical presentation is acute hemodynamic decompensation. However, one of the possible pathomechanisms might be repolarization disturbances. Many of perioperative risk factors of cardiac complications are modifiable. The identification may help in the global perioperative risk reduction.

Aim: The aim of the study was an identification of the factors which may release clinically overt repolarization disturbances.

Methods: The study group consisted of 100 patients, diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure. The authors investigated whether age, gender, comorbidities or some perioperative factors (including hemodynamic, metabolic or genetic) were related to the occurrence of clinically concealed repolarization disturbances or clinically disclosed cardiac complications in postoperative time up to 30 day and one year after vascular surgery procedure.

Detailed description: Vascular surgery is thought as the highest risk procedure in the context of cardiac complications. The range may include acute coronary syndrome, acute circulatory failure, severe arrhythmias, syncope and sudden cardiac death. The patient population is considered as a high risk, too. Popular calculators used for risk stratifications are based on preoperative patient's history and some general laboratory results. However, general status of the patient changes dynamically during vascular procedures leading to acquired increased risk. For this reason, sole preoperative risk prediction based on standard calculators is unsuitable and suboptimal. Advanced monitoring systems may record some temporary disturbances (e.g. ventricular repolarization disturbances), which may be asymptomatic. The clinical significance in postoperative risk prediction of such observations remains undefined. On the other hand, many of perioperative cardiac complications are caused by modifiable factors. The identification may help in the global perioperative risk reduction.

Eligibility criteria: Inclusion Criteria:

* adult patients diagnosed with abdominal subrenal aortic aneurysms or peripheral arterial disease scheduled for an elective "open" vascular surgery procedure

Exclusion Criteria:

* heart stimulation,
* atrioventricular and intraventricular conduction defects,
* atrial fibrillation recorded before of the study,
* antiarrhythmic drug treatment (except beta-blockers),
* unoptimal patient general status (uncontrolled diabetes, active infection)
* reoperation
* emergency operations

Primary outcomes:
measure: cardiac complications
timeFrame: up to 30 days after vascular procedure
Secondary outcomes:
measure: cardiac complications
timeFrame: during surgical procedure
measure: cardiac complications
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anaesthesiology and Intensive Care of the Pomeranian Medical University in Szczecin, Poland.
name: Jowita Biernawska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: