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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03534440
• Other study ID #: DD-TEVAR-2018
• Status: Completed
• Start date: July 1, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: July 2020
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2020
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Aortic
• Aortic Aneurysm
• Diastolic Dysfunction
• Heart Failure

Locations

Country	Name	City	State
Poland	Medical University Of Warsaw	Warsaw	Mazovian

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Hemodynamic parameters: Heart rate	Heart rate during echocardiography evaluation.	Baseline, 2 hours and 24 hours
Secondary	Hemodynamic parameters: Systolic and diastolic pressure	Systolic and diastolic pressure measurements during echocardiography evaluation. Record vasopressors requirement.	Baseline, 2 hours and 24 hours
Secondary	Fluid balance	Monitoring of diuresis hourly, fluid losses and fluids intake	72 hours
Secondary	Kidney function	Monitoring of glomerular filtration rate and requirement for a dialysis daily	72 hours
Secondary	Length of stay in hospital	Documentation of length of stay in hospital since the surgery	up to 14 days
Secondary	Mortality	Documentation of in-hospital mortality and 30 days mortality	up to 30 days