Intraoperative Hypotension and Perioperative Myocardial Injury

Myocardial Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974321
• Other study ID #: 20180713
• Status: Completed
• Start date: May 1, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: March 30, 2020
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension
• Infarction
• Intraoperative Complications
• Intraoperative Hypotension
• Myocardial Infarction
• Myocardial Infarction Postoperative
• Myocardial Injury
• Perioperative Complication
• Wounds and Injuries

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute Myocardial Infarction	Acute MI, detected in the postoperative phase in the electronic medical records or in the Swedeheart Registry	Within 30 days after the index surgery
Secondary	Mortality	Death, detected in the postoperative phase in the Swedish Cause of Death Register.	Witis 30 days after the index surgery and at later predefined time points: 60, 90 180 and 365 days after the index surgery.