NCT01903382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
247,506

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 19, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

Enrollment Period

8.4 years

First QC Date

July 16, 2013

Last Update Submit

November 7, 2014

Conditions

Postoperative Mortality and Morbidity

Outcome Measures

Primary Outcomes (1)

  • Postoperative mortality

    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 Outcomes (1)

  • Hospital length of stay

    One year

Study Arms (1)

Adult patients

All patients undergoing general anesthesia between January 2006 and December 2013

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing general anesthesia between January 2006 and December 2013. They are followed up until hospital discharge.

You may qualify if:

  • All Patients who underwent anesthesia within the study time period.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte and Campus Virchow-Klinikum, Charité - University Medicine

Berlin, State of Berlin, 13353, Germany

Location

Study Officials

  • Claudia Spies, MD Prof.

    Charite University, Berlin, Germany

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charite University, Berlin, Germany

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 19, 2013

Study Start

January 1, 2006

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

DE(1)