Postoperative MortalityKo-MoSkauNCT01810133
Evaluation of Co-morbidity Scales
An observational study of Postoperative Mortality, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status (American Society of Anesthesiology) is the most commonly scale to assess this parameter and has yet been repeatedly criticized in the past for its discriminatory power. Read more about this study
- Who is it for?
- Ages 1 day to 100 years
- Conditions the study is for
- Postoperative Mortality
- How many people
- 230,034 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing general anesthesia between January 2006 and December 2011
Who may be able to join
- 1) All male and female Patients who underwent anesthesia within the study time period (January 2006 and December 2011) in the Charité - University Berlin, Department of Anesthesiology and Intensive Care Medicine CVK/CCM.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine, CVK and CCM, Charité-University
Berlin, Germany, 13353
About this study
Official title: Retrospective Data Analysis: Evaluation of Co-morbidity Scales in Peri-operative Medicine
Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status (American Society of Anesthesiology) is the most commonly scale to assess this parameter and has yet been repeatedly criticized in the past for its discriminatory power.
Few studies have shown both the ASA physical status and the more detailed and more time-consuming Charlson Comorbidity Index to be equivalent in certain patient populations.
The purpose of this observational study is to compare the predictive value of both scales with regards to all-cause in-hospital mortality and hospital length of stay.
- Conditions
- Postoperative Mortality
- Keywords
- Comorbidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Anesthesia patients | All patients undergoing general anesthesia between January 2006 and December 2011 in Charité - University Berlin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients that died after surgery during their hospital stay
Electronic patient charts are revised for the complete hospital length of stay for co-morbidities, intra-operative data and post-operative all-cause in-hospital mortality.
Measured: 1 year
Secondary outcomes (1)
Hospital length of stay associated with surgery
Electronic patient charts are revised for the complete hospital length of stay for co-morbidities, intra-operative data and post-operative all-cause in-hospital mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startJan 2006
- Primary completionOct 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative MortalityStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 230,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810133
- Sponsor's protocol ID
- Ko-MoSkaU
- Acronym
- Ko-MoSkau
- Status last verified
- Oct 2015
- First submitted
- 11 Mar 2013
- Last updated
- 19 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Analysis: Evaluation of Co-morbidity Scales in Peri-operative Medicine
- ClinicalTrials.gov ID
- NCT01810133
- Acronym / sponsor ID
- Ko-MoSkau / Ko-MoSkaU
- Conditions
- Postoperative Mortality
- Keywords
- Comorbidity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230,034 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peri-operative mortality depends on the patient's co-morbidities. ASA Physical Status (American Society of Anesthesiology) is the most commonly scale to assess this parameter and has yet been repeatedly criticized in the past for its discriminatory power.
Few studies have shown both the ASA physical status and the more detailed and more time-consuming Charlson Comorbidity Index to be equivalent in certain patient populations.
The purpose of this observational study is to compare the predictive value of both scales with regards to all-cause in-hospital mortality and hospital length of stay.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anesthesia patients | – | –All patients undergoing general anesthesia between January 2006 and December 2011 in Charité - University Berlin |
Who may qualify
- Ages
- 1 day to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing general anesthesia between January 2006 and December 2011
Key inclusion criteria (1 listed)
- 1) All male and female Patients who underwent anesthesia within the study time period (January 2006 and December 2011) in the Charité - University Berlin, Department of Anesthesiology and Intensive Care Medicine CVK/CCM.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients that died after surgery during their hospital stay
Time frame: 1 year
Electronic patient charts are revised for the complete hospital length of stay for co-morbidities, intra-operative data and post-operative all-cause in-hospital mortality.
1 secondary outcome
Hospital length of stay associated with surgery
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Mortality, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that died after surgery during their hospital stay (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.