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

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ClinicalTrials.gov Identifier: NCT03365726
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : March 19, 2018
Sponsor:
Collaborators:
A.O. Ospedale Papa Giovanni XXIII
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Information provided by (Responsible Party):
Lina Pietropaoli, McGill University Health Center

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.


Condition or disease Intervention/treatment Phase
Mortality After Major Non Cardiac Surgery Diagnostic Test: Dobutamine stress test with trans-esophageal echocardiography Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Intraoperative Stress Test With Dobutamine and Speckle Tracking to Decrease Postoperative Mortality
Actual Study Start Date : January 19, 2016
Actual Primary Completion Date : January 19, 2018
Estimated Study Completion Date : January 19, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DST (dobutamine-stress-test)
dobutamine stress echocardiography performed to patients undergoing major surgery
Diagnostic Test: Dobutamine 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.

No Intervention: NDST (no-dobutamine-stress-test)
patients refused the dobutamine stress test and transesophageal echocardiography measured the troponin level in first 24 hours after surgery



Primary Outcome Measures :
  1. mortality [ Time Frame: 30 days ]
    mortality


Secondary Outcome Measures :
  1. myocardial infarction [ Time Frame: within 30 days after surgery ]
    new ECG changes with troponin increase



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365726


Contacts
Contact: Lina Pietropaoli, MD (514) 825-1387 ext +1 lina.pietropaoli@mail.mcgill.ca
Contact: Francesco Donatelli, MD (514) 501-8891 ext +1 francesco.donatelli@mcgill.ca

Locations
Canada, Quebec
MUHC Recruiting
Montréal, Quebec, Canada
Contact: Francesco Donatelli, MD    (514) 501-8891 ext +1    francesco.donatelli@mcgill.ca   
Contact: Lina Pietropaoli, MD    (514) 825-1387 ext +1    lina.pietropaoli@mail.mcgill.ca   
Principal Investigator: Francesco Donatelli, MD         
Sub-Investigator: Lina Pietropaoli, MD         
Principal Investigator: Ferdinando Luca Lorini, MD         
Sponsors and Collaborators
McGill University Health Center
A.O. Ospedale Papa Giovanni XXIII
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Investigators
Principal Investigator: Francesco Donatelli, MD MUHC - McGill University Health Centre
Principal Investigator: Ferdinando Luca Lorini, MD Ospedale Papa Giovanni XXIII
Study Director: Lina Pietropaoli, MD MUHC - McGill University Health Centre

Publications:

Responsible Party: Lina Pietropaoli, MD, McGill University Health Center
ClinicalTrials.gov Identifier: NCT03365726     History of Changes
Other Study ID Numbers: 15-228-MUHC
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dobutamine
Cardiotonic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents