Assessment of Diastolic Function in High Risk Patients Undergoing Major Vascular Surgery

Completed

• Conditions: Diastolic Dysfunction; Aneurysm Aortic; Heart Failure

• Registration Number: NCT03534440
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Patients scheduled for Thoracic Endovascular Aortic Repair (TEVAR) surgery will have transthoracic echocardiography evaluation of left ventricle diastolic function during the perioperative period.

Detailed Description

Patients undergoing TEVAR surgery are a high risk group of developing perioperative cardiovascular complications.

Left ventricle diastolic dysfunction is common in this group of patients because of the prevalence of risk factors: \> 60 years old, hypertension, smoking history and diabetes.

Because of many predisposing factors that occur during the surgery: stress respond, fluid shifts, anaesthesia and mechanical ventilation. Deterioration of the diastolic function is likely to occur in perioperative period

In this study, the investigators will evaluate change in left ventricle diastolic function as a marker for early detection of a myocardial failure in patients scheduled for an elective TEVAR surgery. The examination will be performed preoperatively, shortly after the surgery and 24 hours after the surgery.

Aim: The aim of the study is to evaluate the diastolic function of left ventricle in perioperative period after high risk surgery. This may provide a valuable information in preoperative risk stratification and postoperative therapy guidance.

Study Timeline

• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-05-21
• Study First Posted: 2018-05-23
• Study Start: 2018-07-01
• Primary Completion: 2019-12-19
• Study Completion: 2020-01-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-05
• Last Update Posted: 2020-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• scheduled TEVAR
• >60 years old

Exclusion Criteria

• Atrial fibrillation or other non-sinus rhythms
• Atrioventricular blocks
• Heart rate change more than 25% postoperatively
• Not adequate transthoracic view
• Postoperative shock
• Sepsis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in left ventricle diastolic function in time	Baseline, 2 hours and 24 hours	Echocardiographic assessment of change in left ventricle diastolic function repeated in time intervals: Baseline before the surgery, 2 and 24 hours after the surgery

Secondary Outcome Measures

Name	Time	Method
Change in biochemistry markers: troponins	Baseline, 2 hours and 24 hours	Assessment of change in level of troponins. Baseline before the surgery, 2 and 24 hours after the surgery
Length of stay in hospital	up to 14 days	Documentation of length of stay in hospital since the surgery
Change in left ventricle systolic function	Baseline, 2 hours and 24 hours	Echocardiographic assessment of change in left ventricle systolic function repeated in time intervals: Baseline before the surgery, 2 and 24 hours after the surgery
Kidney function	72 hours	Monitoring of glomerular filtration rate and requirement for a dialysis daily
Fluid balance	72 hours	Monitoring of diuresis hourly, fluid losses and fluids intake
Change in biochemistry markers: brain natriuretic peptide	Baseline, 2 hours and 24 hours	Assessment of change in level of brain natriuretic peptide. Baseline before the surgery, 2 and 24 hours after the surgery
Hemodynamic parameters: Heart rate	Baseline, 2 hours and 24 hours	Heart rate during echocardiography evaluation.
Hemodynamic parameters: Systolic and diastolic pressure	Baseline, 2 hours and 24 hours	Systolic and diastolic pressure measurements during echocardiography evaluation. Record vasopressors requirement.
Mortality	up to 30 days	Documentation of in-hospital mortality and 30 days mortality

Trial Locations

Locations (1)

Medical University Of Warsaw; 🇵🇱 Warsaw, Mazovian, Poland