Intraoperative Hypotension and Perioperative Myocardial Injury
NCT ID: NCT03974321
Last Updated: 2020-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
600 participants
OBSERVATIONAL
2019-05-01
2020-03-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Obstetric surgery
Controls:
Matched (on age, preoperative risk factors, surgical year- site and procedure) surgical patients without myocardial infarction within 30 days after surgery.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karolinska Institutet
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Max Bell
MD, PhD, Associate Professor, Senior Lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Max Bell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital, Karolinska Institutet
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Karolinska University Hospital
Stockholm, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20180713
Identifier Type: -
Identifier Source: org_study_id