Clinical trial NCT03974321: Intraoperative Hypotension and Perioperative Myocardial Injury
Official title: Association Between Intraoperative Hypotension and Perioperative Myocardial Injury: a Nested Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction Postoperative
Myocardial Injury
Intraoperative Complications
Intraoperative Hypotension
Perioperative Complication
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Acute Myocardial Infarction
timeFrame: Within 30 days after the index surgery
Secondary outcomes:
measure: Mortality
timeFrame: Witis 30 days after the index surgery and at later predefined time points: 60, 90 180 and 365 days after the index surgery.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Karolinska University Hospital, Karolinska Institutet
name: Max Bell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: