Intraoperative Hypotension and Perioperative Myocardial Injury
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|ClinicalTrials.gov Identifier: NCT03974321|
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
|Condition or disease|
|Myocardial Infarction Postoperative Myocardial Injury Intraoperative Complications Intraoperative Hypotension Perioperative Complication|
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 [Patient Registry]|
|Estimated Enrollment :||1200 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||Association Between Intraoperative Hypotension and Perioperative Myocardial Injury: a Nested Case Control Study|
|Actual Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||June 15, 2019|
|Estimated Study Completion Date :||September 30, 2019|
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974321
|Contact: Max Bell, MD, PhD||0046 708 278533||Max.Bell@sll.se|
|Contact: Linn Hallqvist, MD||0046 707 716545||Linn.Hallqvist@sll.se|
|Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Max Bell, MD, PhD 0046 708 278533 Max.Bell@sll.se|
|Contact: Linn Hallqvist, MD 0046 707 716545 Linn.Hallqvist@sll.se|
|Principal Investigator:||Max Bell, MD, PhD||Karolinska University Hospital, Karolinska Institutet|