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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03534440
Enrollment
30
Registered
2018-05-23
Start date
2018-07-01
Completion date
2020-01-30
Last updated
2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysm Aortic, Diastolic Dysfunction, Heart Failure

Keywords

Diastolic Dysfunction, Anesthesia, Preoperative assessment, Postoperative care, TEVAR

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.

Interventions

None listed

Sponsors

Medical University of Warsaw
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in left ventricle diastolic function in timeBaseline, 2 hours and 24 hoursEchocardiographic assessment of change in left ventricle diastolic function repeated in time intervals: Baseline before the surgery, 2 and 24 hours after the surgery

Secondary

MeasureTime frameDescription
Change in biochemistry markers: troponinsBaseline, 2 hours and 24 hoursAssessment of change in level of troponins. Baseline before the surgery, 2 and 24 hours after the surgery
Change in biochemistry markers: brain natriuretic peptideBaseline, 2 hours and 24 hoursAssessment of change in level of brain natriuretic peptide. Baseline before the surgery, 2 and 24 hours after the surgery
Change in left ventricle systolic functionBaseline, 2 hours and 24 hoursEchocardiographic assessment of change in left ventricle systolic function repeated in time intervals: Baseline before the surgery, 2 and 24 hours after the surgery
Hemodynamic parameters: Heart rateBaseline, 2 hours and 24 hoursHeart rate during echocardiography evaluation.
Mortalityup to 30 daysDocumentation of in-hospital mortality and 30 days mortality
Fluid balance72 hoursMonitoring of diuresis hourly, fluid losses and fluids intake
Kidney function72 hoursMonitoring of glomerular filtration rate and requirement for a dialysis daily
Length of stay in hospitalup to 14 daysDocumentation of length of stay in hospital since the surgery
Hemodynamic parameters: Systolic and diastolic pressureBaseline, 2 hours and 24 hoursSystolic and diastolic pressure measurements during echocardiography evaluation. Record vasopressors requirement.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026