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Intraoperative Hypotension and Perioperative Myocardial Injury

Association Between Intraoperative Hypotension and Perioperative Myocardial Injury: a Nested Case Control Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03974321
Enrollment
600
Registered
2019-06-04
Start date
2019-05-01
Completion date
2020-03-30
Last updated
2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Complications, Intraoperative Hypotension, Myocardial Infarction Postoperative, Myocardial Injury, Perioperative Complication

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.

Interventions

None listed

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Acute Myocardial InfarctionWithin 30 days after the index surgeryAcute MI, detected in the postoperative phase in the electronic medical records or in the Swedeheart Registry

Secondary

MeasureTime frameDescription
MortalityWitis 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.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026