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Completed

NCT Number: NCT03974321

Intraoperative Hypotension and Perioperative Myocardial Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jun 4, 2019
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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