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

Not Applicable

• Conditions: Mortality After Major Non Cardiac Surgery
• Interventions: Diagnostic Test: Dobutamine stress test with trans-esophageal echocardiography

• Registration Number: NCT03365726
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-19
• Study First Submitted: 2017-11-22
• Study First Submitted QC: 2017-12-01
• Study First Posted: 2017-12-07
• Primary Completion: 2018-01-19
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-15
• Last Update Posted: 2018-03-19
• Study Completion: 2019-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DST (dobutamine-stress-test)	Dobutamine stress test with trans-esophageal echocardiography	dobutamine stress echocardiography performed to patients undergoing major surgery

Primary Outcome Measures

Name	Time	Method
mortality	30 days	mortality

Secondary Outcome Measures

Name	Time	Method
myocardial infarction	within 30 days after surgery	new ECG changes with troponin increase

Trial Locations

Locations (1)

MUHC; 🇨🇦 Montréal, Quebec, Canada