- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03938480
Duration Threstholds of Intraoperative Hypotension
June 3, 2019 updated by: Yan Zhou, MD, Peking University First Hospital
Duration Threstholds of Intraoperative Hypotension for Postoperative Major Adverse Events
Intraoperative hypotension is common in non cardiac surgery.
longer duration of intraoperative hypotension is related with postoperative morbidity and mortality.
however, with the change of hypotension criteria, the duration threshold also change.
the relationship of different hypotension criteria and its duration is unclear.
This study is to explore the their relationship.
Study Overview
Status
Completed
Conditions
Detailed Description
Intraoperative hypotension is common in non cardiac surgery.
longer duration of intraoperative hypotension is related with postoperative morbidity and mortality.
however, with the change of hypotension criteria, the duration threshold also change.
the relationship of different hypotension criteria and its duration is unclear.
This study is to explore the relationship between continous difference mean blood pressure criteria and its duration thresholds for postoperative major adverse events, which include acute cardiac infarction, heart failure, cardiac death, stroke and acute kidney injury.
Study Type
Observational
Enrollment (Actual)
37000
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
-
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Beijing
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Beijing, Beijing, China
- PKU 1st 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 to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The analysis set of this study was adults (age ≥ 18 years old) who underwent elective non-cardiac surgery from January 1, 2012, to December 31, 2017.
Description
Inclusion Criteria:
adults underwent elective non-cardiac surgery
Exclusion Criteria:
cardiac surgeries; kidney surgeries; obstetric surgeries; local infiltration anesthesia; surgeries without arterial pressure monitoring; perioperative data missing; patients with more than one operation within a year
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 |
---|---|---|
major adverse events
Time Frame: 30 days postoperatively in hospital
|
including acute cardiac infarction, heart failure, cardiac death, stroke, kidney injury
|
30 days postoperatively in hospital
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2019
Primary Completion (Actual)
May 20, 2019
Study Completion (Actual)
May 22, 2019
Study Registration Dates
First Submitted
May 2, 2019
First Submitted That Met QC Criteria
May 2, 2019
First Posted (Actual)
May 6, 2019
Study Record Updates
Last Update Posted (Actual)
June 4, 2019
Last Update Submitted That Met QC Criteria
June 3, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DTIH
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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