- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02706457
Post Intensive Care Syndrome
April 11, 2016 updated by: Matty Koopmans, Medical Centre Leeuwarden
Do Improvements in Functionality on the ICU Give a Reduction of Post Intensive Care Syndrome
Barthel Index and demographic variables of patients were collected to investigate the question whether the improvements of the functionality improves the Barthel Index over the years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
idem
Study Type
Observational
Enrollment (Actual)
849
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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Leeuwarden, Netherlands, 8904 BR
- Medical center Leeuwarden
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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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients treated in Intensive Care for minimal 48 hours, during the years 2012 - 2014
Description
Inclusion Criteria:
- 18 years and older
- length of stay longer than 48 hours
Exclusion Criteria:
- no exclusion criteria if inclusion is correct
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 |
Intervention / Treatment |
|---|---|
|
cohort 2012 - 2014
all patients admitted for > 48 hours on the Intensive Care Unit in 2012, 2013 and 2014
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The Barthel Index for functionality is done standard in all patients after intensive care admission
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in Barthel Index
Time Frame: from januari 2012 until decembre 2014
|
barthel index is analyzed over the years 2012 - 2014
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from januari 2012 until decembre 2014
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Relation between Barthel Index and length of stay in ICU
Time Frame: from januari 2012 until decembre 2014
|
from januari 2012 until decembre 2014
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Matty Koopmans, MSc, MCL
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
October 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
February 16, 2016
First Submitted That Met QC Criteria
March 7, 2016
First Posted (Estimate)
March 11, 2016
Study Record Updates
Last Update Posted (Estimate)
April 12, 2016
Last Update Submitted That Met QC Criteria
April 11, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- nWMO 143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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.