Intraoperative Dobutamine Stress Test With Speckle Tracking to Decrease Postoperative Mortality (ISTMO)

Study Overview
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Brief Summary
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Perioperative adverse cardiovascular events are the leading cause of morbidity and mortality after noncardiac surgery. The implications of perioperative cardiac complications on morbidity and mortality, in-hospital and long-term care, and resource utilization are enormous. The continuously increasing proportion of elderly patients presenting for noncardiac surgery raises serious concerns regarding adverse cardiac events in the perioperative period. The responsibility for early diagnosis and prompt treatment of cardiac complications during surgery rests squarely with the anesthesiologist. Reliable intraoperative identification of patients at high risk for postoperative AMI and/or death is currently inadequate, but may confer substantial benefits to patients as preventive measures could be instituted. A reliable and reproducible quantitative measure of regional and global myocardial function could improve preoperative risk stratification and guide anesthetic management when acute changes in myocardial function occur. In the present study is hypothesized that intraoperative dobutamine stress echocardiography by 2-dimensional speckle tracking echocardiography can identify patients at higher risk of perioperative adverse cardiac events.

Official Title
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Intraoperative Stress Test With Dobutamine and Speckle Tracking to Decrease Postoperative Mortality

Conditions
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Mortality After Major Non Cardiac Surgery

Intervention / Treatment
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* Diagnostic Test: Dobutamine stress test with trans-esophageal echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any laparotomy Any thoracotomy Any hip surgery Any complex oncologic surgery o Any thoracoscopy Exclusion Criteria: Females older than 80 year old Patients on chronic systemic corticosteroid therapy Diagnosed pharyngeal or gastro-esophageal pathologies (such as esophageal varices, stricture, diverticula, tumor, esophagitis, Mallory- Weiss tear, or previous surgery for any of these) Signs and symptoms of severe pharyngeal or gastro-esophageal pathologies (including odynophagia, dysphagia) Emergency surgery Age less than 50 year old

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DST (dobutamine-stress-test)<br>dobutamine stress echocardiography performed to patients undergoing major surgery | Diagnostic Test: Dobutamine stress test with trans-esophageal echocardiography<br>* Dobutamine stress echocardiography will be performed: before skin incision and at the end of surgery. After a TEE evaluation at rest to assess myocardial structure, function and potential regional wall motion abnormalities, dobutamine infusion will be started If no regional wall motion abnormalities will be detected, a dobutamine stress echocardiography will be started at the range infusion of 50 γ/kg/min (ADST: Accelerated Dobutamine Stress Test). The Test will be continued up to the 85% of maximum heart rate adjusted for the patient age and echo images will be stored. If regional wall motion abnormalities are present, a gradual dobutamine stress test will be started at the initial dose of 10 mcg/kg/min (GDST: Gradual Dobutamine Stress Test) and it will be increased every 3 minutes until the 85% of maximum heart rate, adjusted for patient's age (maximal dose: 40 mcg/kg/min) and echo images will be stored.<br>|
| No Intervention: NDST (no-dobutamine-stress-test)<br>patients refused the dobutamine stress test and transesophageal echocardiography measured the troponin level in first 24 hours after surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial infarction | new ECG changes with troponin increase | within 30 days after surgery |