Association Between Intraoperative Hypotension and Perioperative Myocardial Injury: a Nested Case Control Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Acute Myocardial Infarction
Study Overview
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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Acute myocardial infarction criteria fulfilled within 30 days after surgery.
Exclusion Criteria
- •Cardiac surgery
- •Obstetric surgery
- •Matched (on age, preoperative risk factors, surgical year- site and procedure) surgical patients without myocardial infarction within 30 days after surgery.
Outcomes
Primary Outcomes
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 Outcomes
- Mortality(Witis 30 days after the index surgery and at later predefined time points: 60, 90 180 and 365 days after the index surgery.)
Investigators
Max Bell
MD, PhD, Associate Professor, Senior Lecturer
Karolinska Institutet