Clinical trial NCT03365726: Intraoperative Dobutamine Stress Test With Speckle Tracking to Decrease Postoperative Mortality (ISTMO)
Official title: Intraoperative Stress Test With Dobutamine and Speckle Tracking to Decrease Postoperative Mortality
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mortality After Major Non Cardiac Surgery
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: A.O. Ospedale Papa Giovanni XXIII
name: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
First posted: 2017-12-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: mortality
timeFrame: 30 days
Secondary outcomes:
measure: myocardial infarction
timeFrame: within 30 days after surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: MUHC
state: Quebec
Study officials:
affiliation: MUHC - McGill University Health Centre
name: Francesco Donatelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Papa Giovanni XXIII
name: Ferdinando Luca Lorini, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MUHC - McGill University Health Centre
name: Lina Pietropaoli, MD
role: STUDY_DIRECTOR
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