Clinical trial NCT03534440: Assessment of Diastolic Function in High Risk Patients Undergoing Major Vascular Surgery
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diastolic Dysfunction
Heart Failure
Aneurysm Aortic
Keywords: Diastolic Dysfunction
Anesthesia
Preoperative assessment
Postoperative care
TEVAR
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for a Thoracic Endovascular Aortic Repair

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.

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
* Sepsis

Primary outcomes:
measure: Change in left ventricle diastolic function in time
timeFrame: Baseline, 2 hours and 24 hours
Secondary outcomes:
measure: Change in biochemistry markers: troponins
timeFrame: Baseline, 2 hours and 24 hours
measure: Change in biochemistry markers: brain natriuretic peptide
timeFrame: Baseline, 2 hours and 24 hours
measure: Change in left ventricle systolic function
timeFrame: Baseline, 2 hours and 24 hours
measure: Hemodynamic parameters: Heart rate
timeFrame: Baseline, 2 hours and 24 hours
measure: Hemodynamic parameters: Systolic and diastolic pressure
timeFrame: Baseline, 2 hours and 24 hours
measure: Fluid balance
timeFrame: 72 hours
measure: Kidney function
timeFrame: 72 hours
measure: Length of stay in hospital
timeFrame: up to 14 days
measure: Mortality
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University Of Warsaw
state: Mazovian
Study officials:
References: