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Circadian, Weekly and Seasonal Variability of Postoperative Mortality and Morbidity (Zirkadianest)

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ClinicalTrials.gov Identifier: NCT01903382
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : November 10, 2014
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany

Brief Summary:
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.

Condition or disease
Postoperative Mortality and Morbidity

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Study Type : Observational
Actual Enrollment : 247506 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Association Between Circadian, Weekly, and Seasonal Effects and Time of Surgery on Postoperative Morbidity and Mortality of Patients (Zirkadianest)
Study Start Date : January 2006
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Group/Cohort
Adult patients
All patients undergoing general anesthesia between January 2006 and December 2013



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

All Patients who underwent anesthesia within the study time period.

Exclusion Criteria:

none


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903382


Locations
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Germany
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - University Medicine
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
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Study Director: Claudia Spies, MD Prof. Charite University, Berlin, Germany

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Responsible Party: Claudia Spies, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01903382     History of Changes
Other Study ID Numbers: Zirkadianest
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014