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UnknownNCT03365726

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
2,000 (estimated)
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
Sex
All
Age
50 Years – 80 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTDobutamine stress test with trans-esophageal echocardiographyDobutamine 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.

Timeline

Start date
2016-01-19
Primary completion
2018-01-19
Completion
2019-01-19
First posted
2017-12-07
Last updated
2018-03-19

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT03365726. Inclusion in this directory is not an endorsement.