NCT04109001

Brief Summary

In this study the investigators will validate the impact of comorbidity on readmission to intensive care unit (ICU) and mortality after ICU and which method of measuring comorbidity that is most predictive. The study population included all critical care patients' registries in Swedish intensive care registry (SIR) during the years 2005 to 2012 with valid personal identity number. Data from Statistics Sweden och National Board of Health and Welfare were linked to data from SIR and de-identified. Hospital discharge diagnoses from five year preceding the index date for the ICU admission were extracted. A composite outcome of death and readmission will be analyzed. Analyzes with cox proportional-hazards regression, time to event, on the training data set year 2005-2010 The study population will be split in a training data set (2005-10) and a test data set (2011-12) for validating our prognostic model. The predictive ability in the test data set were evaluated based on discrimination, AUC (C index), Calibration and Brier score.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
223,495

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

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, 2005

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

11 years

First QC Date

September 26, 2019

Last Update Submit

January 7, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • The ability of comorbidity to predict death after intensive care

    A composite outcome of death and readmission will be analyzed. Death and readmission will also be analyzed separately. Follow-up starts at admission. A binary status variable (no/yes) is created reflecting if the outcome has happened or not together with a corresponding time variable.

    For each admission the follow-up ends with readmission, death or end of study (2016-12-31) whichever comes first.

  • The ability of comorbidity to predict readmission after intensive care

    A composite outcome of death and readmission will be analyzed. Death and readmission will also be analyzed separately. Follow-up starts at admission. A binary status variable (no/yes) is created reflecting if the outcome has happened or not together with a corresponding time variable.

    For each admission the follow-up ends with readmission, death or end of study (2016-12-31) whichever comes first.

Eligibility Criteria

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

All critical care patients' registries in SIR during the years 2005 to 2012 with valid personal identity number.

You may qualify if:

  • All critical care patients' registries in SIR during the years 2005 to 2012
  • Valid personal identity number

You may not qualify if:

  • Age 16 and older
  • No valid personal identity number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Christensen S, Johansen MB, Christiansen CF, Jensen R, Lemeshow S. Comparison of Charlson comorbidity index with SAPS and APACHE scores for prediction of mortality following intensive care. Clin Epidemiol. 2011;3:203-11. doi: 10.2147/CLEP.S20247. Epub 2011 Jun 17.

    PMID: 21750629BACKGROUND
  • Cook RJ, Lawless JF. Analysis of repeated events. Stat Methods Med Res. 2002 Apr;11(2):141-66. doi: 10.1191/0962280202sm278ra.

    PMID: 12040694BACKGROUND
  • Elixhauser A, Steiner C, Harris DR, Coffey RM. Comorbidity measures for use with administrative data. Med Care. 1998 Jan;36(1):8-27. doi: 10.1097/00005650-199801000-00004.

    PMID: 9431328BACKGROUND
  • Aronsson Dannewitz A, Svennblad B, Michaelsson K, Lipcsey M, Gedeborg R. Optimized diagnosis-based comorbidity measures for all-cause mortality prediction in a national population-based ICU population. Crit Care. 2022 Oct 6;26(1):306. doi: 10.1186/s13054-022-04172-0.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2019

First Posted

September 30, 2019

Study Start

January 1, 2005

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

January 10, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

To minimize the risk of data coming into the wrong hands, after linking the data sources personal numbers replaced with anonymous serial numbers. The data then does not leave statistic Sweden and the database MONA, and are only available to qualified researchers. All analysis and statistical processing is thus done at Statistics Sweden and only results can be obtained from there. All reporting is done at group level. If the study wants to be replicated, data from the same period can be extracted from the above mentioned register.