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Intraoperative Hypotension and Perioperative Myocardial Injury
| Condition or disease |
|---|
| Myocardial Infarction Postoperative Myocardial Injury Intraoperative Complications Intraoperative Hypotension Perioperative Complication |
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 [Patient Registry] |
| Actual Enrollment : | 600 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| 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 |
| Actual Primary Completion Date : | June 15, 2019 |
| Actual Study Completion Date : | March 30, 2020 |
- 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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
| Sweden | |
| Karolinska University Hospital | |
| Stockholm, Sweden, 17176 | |
| Principal Investigator: | Max Bell, MD, PhD | Karolinska University Hospital, Karolinska Institutet |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 2, 2019 | ||||
| First Posted Date | June 4, 2019 | ||||
| Last Update Posted Date | October 26, 2020 | ||||
| Actual Study Start Date | May 1, 2019 | ||||
| Actual Primary Completion Date | June 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
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.
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Intraoperative Hypotension and Perioperative Myocardial Injury | ||||
| Official Title | Association Between Intraoperative Hypotension and Perioperative Myocardial Injury: a Nested Case Control Study | ||||
| Brief 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. | ||||
| 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. |
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| Study Type | Observational [Patient Registry] | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | 1 Year | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
600 | ||||
| Original Estimated Enrollment |
1200 | ||||
| Actual Study Completion Date | March 30, 2020 | ||||
| Actual Primary Completion Date | June 15, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Cases Inclusion Criteria:
Exclusion Criteria:
Controls: Matched (on age, preoperative risk factors, surgical year- site and procedure) surgical patients without myocardial infarction within 30 days after surgery. |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Sweden | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03974321 | ||||
| Other Study ID Numbers | 20180713 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Max Bell, Karolinska Institutet | ||||
| Study Sponsor | Karolinska Institutet | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Karolinska Institutet | ||||
| Verification Date | October 2020 | ||||
