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Completed

NCT Number: NCT03534440

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

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

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Key information

Conditions

Diastolic Dysfunction Aneurysm Aneurysm Aortic Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Heart Diseases Heart Failure Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Of Warsaw

Warsaw, Mazovian, 02-091, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Change in biochemistry markers: troponins

    Time frame: Baseline, 2 hours and 24 hours

    Assessment of change in level of troponins. Baseline before the surgery, 2 and 24 hours after the surgery

  2. Change in biochemistry markers: brain natriuretic peptide

    Time frame: Baseline, 2 hours and 24 hours

    Assessment of change in level of brain natriuretic peptide. Baseline before the surgery, 2 and 24 hours after the surgery

  3. Change in left ventricle systolic function

    Time frame: Baseline, 2 hours and 24 hours

    Echocardiographic assessment of change in left ventricle systolic function repeated in time intervals:

    Baseline before the surgery, 2 and 24 hours after the surgery

  4. Hemodynamic parameters: Heart rate

    Time frame: Baseline, 2 hours and 24 hours

    Heart rate during echocardiography evaluation.

  5. Hemodynamic parameters: Systolic and diastolic pressure

    Time frame: Baseline, 2 hours and 24 hours

    Systolic and diastolic pressure measurements during echocardiography evaluation. Record vasopressors requirement.

  6. Fluid balance

    Time frame: 72 hours

    Monitoring of diuresis hourly, fluid losses and fluids intake

  7. Kidney function

    Time frame: 72 hours

    Monitoring of glomerular filtration rate and requirement for a dialysis daily

  8. Length of stay in hospital

    Time frame: up to 14 days

    Documentation of length of stay in hospital since the surgery

  9. Mortality

    Time frame: up to 30 days

    Documentation of in-hospital mortality and 30 days mortality

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
May 23, 2018
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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