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

Assessment of Left Ventricle Diastolic Function in High Risk Patients Undergoing Major Vascular Surgery as an Early Indicator of Cardiac Failure. Observational Study

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Diastolic Dysfunction; Aneurysm Aortic

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Poland
  • Mazovian
    • Warsaw, Mazovian, Poland, 02-091
      • Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for a Thoracic Endovascular Aortic Repair

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): January 30, 2020

Study Registration Dates

• First Submitted: April 15, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 5, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative care; Anesthesia; TEVAR; Diastolic Dysfunction; Preoperative assessment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: DD-TEVAR-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No