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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
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03365726
Acronym
ISTMO
Enrollment
140
Registered
2017-12-07
Start date
2016-01-19
Completion date
2021-01-19
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mortality After Major Non Cardiac Surgery

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

Due to changes in study execution, analyses focused on prospectively collected physiological data examining myocardial contractile reserve and its association with postoperative myocardial injury

Interventions

DIAGNOSTIC_TESTDobutamine stress test with trans-esophageal echocardiography

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.

Sponsors

McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER
A.O. Ospedale Papa Giovanni XXIII
CollaboratorOTHER
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
mortality30 daysmortality

Secondary

MeasureTime frameDescription
myocardial infarctionwithin 30 days after surgerynew ECG changes with troponin increase

Countries

Canada

Contacts

PRINCIPAL_INVESTIGATORFrancesco Donatelli, MD

MUHC - McGill University Health Centre

PRINCIPAL_INVESTIGATORFerdinando Luca Lorini, MD

Ospedale Papa Giovanni XXIII

STUDY_DIRECTORLina Pietropaoli, MD, PhD

MUHC - McGill University Health Centre

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 12, 2026