Cardiac Complication After Vascular Surgery

NCT ID: NCT03188341

Last Updated: 2017-06-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2017-06-30

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.

Conditions

Aortic Aneurysm, Abdominal; Ventricular Arrythmia; Peripheral Arterial Disease; Cardiac Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

vascular surgery patients

• clinically concealed repolarization disturbances during vascular surgery procedure
• clinically disclosed cardiac complications during and after vascular surgery procedure

vascular surgery procedure

Intervention Type: OTHER

• an elective "open" vascular surgery procedure
• ECG Holter recording during the procedure and 24 hours after operation (continuous electrocardiographic tracing (digital Holter ECG monitor)

Interventions

vascular surgery procedure

• an elective "open" vascular surgery procedure
• ECG Holter recording during the procedure and 24 hours after operation (continuous electrocardiographic tracing (digital Holter ECG monitor)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pomeranian Medical University Szczecin

OTHER

Sponsor Role: lead

Responsible Party

Jowita Biernawska

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jowita Biernawska, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology and Intensive Care of the Pomeranian Medical University in Szczecin, Poland.

Other Identifiers

PomeranianMU

Identifier Type: -

Identifier Source: org_study_id