- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01903382
Circadian, Weekly and Seasonal Variability of Postoperative Mortality and Morbidity (Zirkadianest)
November 7, 2014 updated by: Claudia Spies, Charite University, Berlin, Germany
The Association Between Circadian, Weekly, and Seasonal Effects and Time of Surgery on Postoperative Morbidity and Mortality of Patients (Zirkadianest)
Mortality is subject to cyclic variability: circadian, weekly, and seasonal.
This has been shown for different populations, different diseases and in different countries, but not for surgical patients.
Aim of this study is therefore to investigate the association between circadian, weekly, and seasonal effects time of surgery postoperative mortality of patients undergoing surgery and general anesthesia.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
247506
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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Berlin, Germany, 13353
- Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - University Medicine
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients undergoing general anesthesia between January 2006 and December 2013.
They are followed up until hospital discharge.
Description
Inclusion Criteria:
All Patients who underwent anesthesia within the study time period.
Exclusion Criteria:
none
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Adult patients
All patients undergoing general anesthesia between January 2006 and December 2013
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative mortality
Time Frame: One year
|
The primary objective of this study is to show associations between postoperative mortality and circadian, weekly and seasonal rhythms. Electronic patient charts are revised for complete hospital length of stay for time of surgery, co-morbidities, intra-operative data and all-cause in-hospital mortality |
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital length of stay
Time Frame: One year
|
The secondary objective of this is to show associations between hospital length of stay and circadian, weekly and seasonal rhythms.
Electronic patient charts are revised for complete hospital length of stay for time of surgery, co-morbidities, intra-operative data and hospital length of stay
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
January 1, 2006
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 16, 2013
First Submitted That Met QC Criteria
July 16, 2013
First Posted (Estimate)
July 19, 2013
Study Record Updates
Last Update Posted (Estimate)
November 10, 2014
Last Update Submitted That Met QC Criteria
November 7, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- Zirkadianest
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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