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Intraoperative Hypotension and Perioperative Myocardial Injury

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ClinicalTrials.gov Identifier: NCT03974321
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
Max Bell, Karolinska Institutet

Brief Summary:
Acute myocardial infarction (MI) is a significant complication following non-cardiac surgery. We sought to evaluate incidence of perioperative MI, its preoperative - and intraoperative - risk factors and outcomes after this complication.

Condition or disease
Myocardial Infarction Postoperative Myocardial Injury Intraoperative Complications Intraoperative Hypotension Perioperative Complication

Detailed Description:

Background:

In Sweden, over 800 000 patents undergo surgery each year. Worldwide, the number of surgical procedures yearly is over 310 million. Surgical care is en essential part of the advancement in treating disease, associated with increased lift expectancy a d improved quality of life. However as surgical volume continues to grow, the number of patients who suffer postoperative complications will also increase.

Hemodynamic instability in the perioperative period is frequent and there has been a cumulative interest in this area and the relation to organ failure over the recent years. There are several studies showing results of associations between intraoperative hypotensive events and perioperative cardiac, kidney and cerebral injury, as well as increased mortality in high-risk surgical patients.

More specifically the project aims to answer how intraoperative events, with a special focus on hypotension, are related to perioperative myocardial and kidney injury.

We hypothesize that patients, with preoperative risk factors, undergoing major non-cardiac surgery are at increased risk of developing perioperative organ damage in the presence of intraoperative hypotension or other events such as tachycardia, hypoxia and extensive blood loss.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Association Between Intraoperative Hypotension and Perioperative Myocardial Injury: a Nested Case Control Study
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 15, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Acute Myocardial Infarction [ Time Frame: Within 30 days after the index surgery ]
    Acute MI, detected in the postoperative phase in the electronic medical records or in the Swedeheart Registry


Secondary Outcome Measures :
  1. Mortality [ Time Frame: Witis 30 days after the index surgery and at later predefined time points: 60, 90 180 and 365 days after the index surgery. ]
    Death, detected in the postoperative phase in the Swedish Cause of Death Register.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing non-cardiac surgery between 2007 and 2014 at 3 Swedish University hospitals; Karolinska University hospital, Skåne University Hospital and Norrland University hospital.
Criteria

Cases

Inclusion Criteria:

  • Adults (≥18 years), male and female.
  • Undergoing elective or non-elective in-patients non-cardiac surgery at 3 University Hospitals in Sweden: Karolinska University hospital, Skåne University hospital and Norrland University hospital.
  • Surgeries performed between 2007 and 2014.
  • Acute myocardial infarction criteria fulfilled within 30 days after surgery.

Exclusion Criteria:

  • Cardiac surgery
  • Obstetric surgery

Controls:

Matched (on age, preoperative risk factors, surgical year- site and procedure) surgical patients without myocardial infarction within 30 days after surgery.


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): NCT03974321


Contacts
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Contact: Max Bell, MD, PhD 0046 708 278533 Max.Bell@sll.se
Contact: Linn Hallqvist, MD 0046 707 716545 Linn.Hallqvist@sll.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Max Bell, MD, PhD    0046 708 278533    Max.Bell@sll.se   
Contact: Linn Hallqvist, MD    0046 707 716545    Linn.Hallqvist@sll.se   
Sponsors and Collaborators
Karolinska Institutet
Investigators
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Principal Investigator: Max Bell, MD, PhD Karolinska University Hospital, Karolinska Institutet

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Responsible Party: Max Bell, MD, PhD, Associate Professor, Senior Lecturer, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03974321     History of Changes
Other Study ID Numbers: 20180713
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019

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

Additional relevant MeSH terms:
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Myocardial Infarction
Hypotension
Infarction
Intraoperative Complications
Wounds and Injuries
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases