- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01278524
International Multicenter Study One Day Prevalence Observational Study for Delirium on ICU (IMPROVE-ICU)
August 9, 2013 updated by: Claudia Spies
An anonymous international multicenter - clinical survey, one-day observational study.
Study Overview
Status
Completed
Conditions
Detailed Description
Delirium is a serious complication in postoperative and critically ill patients and is independently associated with cognitive impairment at hospital discharge and with significantly higher 6-month mortality.
Furthermore, ICU delirium is associated with more days requiring mechanically ventilation, longer ICU length of stay, and longer hospital length of stay.
More recently a study by Pisani and co-workers' could show an association between days of delirium and mortality; - each additional day spent in delirium is associated with a 20% increased risk of prolonged hospitalization - translating to over 10 additional days - and a 10% increased risk of death.The reported prevalence of delirium in critically ill patients ranges widely from 11% to 87%.
The aim of our study is to investigate the implementation rate of routine delirium assessment in European ICUs.
Study Type
Observational
Enrollment (Actual)
1002
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
-
-
-
Berlin, Germany, 13353
- Department of Anesthesiology and Intensive Care Medicine, Campus Virchow-Klinikum and Campus Charité Mitte, Charité - Universitaetsmedizin Berlin
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
ICU patients
Description
Inclusion Criteria:
- Patients staying in the ICU on the 25th of January (one-day prevalence study)
No exclusion Criteria:
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
Cohorts and Interventions
Group / Cohort |
---|
Critically ill patients
Patients staying in the ICU on the 25th of January
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Implementation rate of routine delirium assessment
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Point prevalence of ICU delirium
Time Frame: 24 hours
|
24 hours
|
Methodology of delirium assessment (e.g. type of score, frequency of evaluation)
Time Frame: 24 hours
|
24 hours
|
Non-pharmacological treatment-/prevention strategies
Time Frame: 24 hours
|
24 hours
|
Drugs used for delirium treatment
Time Frame: 24 hours
|
24 hours
|
Sedation practices (e.g. scales, daily sedation goals, SBT - spontaneous breathing trials, SAT - spontaneous awakening trials)
Time Frame: 24 hours
|
24 hours
|
Analgesia regimes (e.g. scales)
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Claudia Spies, MD, Charite - Universitaetsmedizin Berlin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2011
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
January 18, 2011
First Submitted That Met QC Criteria
January 18, 2011
First Posted (Estimate)
January 19, 2011
Study Record Updates
Last Update Posted (Estimate)
August 13, 2013
Last Update Submitted That Met QC Criteria
August 9, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMPROVE-ICU
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.
Clinical Trials on Delirium
-
Efficacy Care R&D LtdHadassah Medical OrganizationUnknownDelirium | Delirium, Cause Unknown | Delirium of Mixed Origin | Delirium Confusional State | Delirium Drug-InducedIsrael
-
Imperial College Healthcare NHS TrustRecruitingCardiac Surgery | Intensive Care Unit Delirium | Post Operative DeliriumUnited Kingdom
-
Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicRecruitingDelirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional StateNorway
-
Menoufia UniversityCompleted
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingDelirium | Delirium on Emergence | Hearing Loss | Hearing Loss, High-Frequency | Hearing Loss, Sensorineural | Delirium, Cause Unknown | Hearing Loss, Bilateral | Hearing Disability | Delirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional State | Delirium With... and other conditionsUnited States
-
Universidad de SantanderUnknownDelirium of Mixed Origin | Hypoactive Delirium | Hyperactive DeliriumColombia
-
Chinese PLA General HospitalBeijing Tiantan HospitalRecruiting
-
Charite University, Berlin, GermanyBARMERRecruitingDelirium in Old AgeGermany
-
Mayo ClinicCompletedPost-Operative DeliriumUnited States
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland