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

McGill University logo

McGill University

Status

Unknown

Conditions

Mortality After Major Non Cardiac Surgery

Treatments

Diagnostic Test: Dobutamine stress test with trans-esophageal echocardiography

Study type

Interventional

Funder types

Other

Identifiers

NCT03365726
15-228-MUHC

Details and patient eligibility

About

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.

Enrollment

2,000 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2,000 participants in 2 patient groups

DST (dobutamine-stress-test)
Experimental group
Description:
dobutamine stress echocardiography performed to patients undergoing major surgery
Treatment:
Diagnostic Test: Dobutamine stress test with trans-esophageal echocardiography
NDST (no-dobutamine-stress-test)
No Intervention group
Description:
patients refused the dobutamine stress test and transesophageal echocardiography measured the troponin level in first 24 hours after surgery

Trial contacts and locations

1

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Central trial contact

Lina Pietropaoli, MD; Francesco Donatelli, MD

Data sourced from clinicaltrials.gov

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