Intraoperative Hypotension and Perioperative Myocardial Injury

October 23, 2020 updated by: Max Bell, Karolinska Institutet

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 30 days after the index surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Witis 30 days after the index surgery and at later predefined time points: 60, 90 180 and 365 days after the index surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2019

Primary Completion (ACTUAL)

June 15, 2019

Study Completion (ACTUAL)

March 30, 2020

Study Registration Dates

First Submitted

June 2, 2019

First Submitted That Met QC Criteria

June 3, 2019

First Posted (ACTUAL)

June 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2020

Last Update Submitted That Met QC Criteria

October 23, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180713

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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