Cardiac Complication After Vascular Surgery

NCT03188341 | Completed

• 1 other identifier: PomeranianMU
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

vascular surgery; repolarization disturbances; cardiac complications; high risk patient; high risk procedure

Outcome Measures

Primary Outcomes (1)

• cardiac complications

  cardiac complications according to European Society of Cardiology

  up to 30 days after vascular procedure

Secondary Outcomes (2)

• cardiac complications

  during surgical procedure

• cardiac complications

  one year

Study Arms (1)

vascular surgery patients

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

Other: vascular surgery procedure

Interventions

vascular surgery procedure 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)

vascular surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Biospecimen

Retention: SAMPLES WITH DNA

Metabolic monitoring consisted of electrolytes and arterial blood gas analysis prior to anesthesia induction and at the end of the procedure. Blood was drawn into anticoagulant for genetic studies. Genomic DNA was isolated from peripheral blood leukocytes to investigate rs203462 AKAP10 polymorphism in the study population.

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Peripheral Arterial Disease

Interventions

Vascular Surgical Procedures

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jowita Biernawska, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 15, 2017
• Study Start: December 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share