Skip to main content
Clinical Trials/NCT03534440
NCT03534440
Completed
N/A

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

Medical University of Warsaw1 site in 1 country30 target enrollmentJuly 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diastolic Dysfunction
Sponsor
Medical University of Warsaw
Enrollment
30
Locations
1
Primary Endpoint
Change in left ventricle diastolic function in time
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
January 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical University of Warsaw
Responsible Party
Principal Investigator
Principal Investigator

Mateusz Zawadka

Principal Investigator

Medical University of Warsaw

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in left ventricle diastolic function in time

Time Frame: 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 Outcomes

  • Change in biochemistry markers: troponins(Baseline, 2 hours and 24 hours)
  • Length of stay in hospital(up to 14 days)
  • Change in left ventricle systolic function(Baseline, 2 hours and 24 hours)
  • Kidney function(72 hours)
  • Fluid balance(72 hours)
  • Change in biochemistry markers: brain natriuretic peptide(Baseline, 2 hours and 24 hours)
  • Hemodynamic parameters: Heart rate(Baseline, 2 hours and 24 hours)
  • Hemodynamic parameters: Systolic and diastolic pressure(Baseline, 2 hours and 24 hours)
  • Mortality(up to 30 days)

Study Sites (1)

Loading locations...

Similar Trials