Contact information
Type
Scientific
Primary contact
Prof Claudia Spies
ORCID ID
Contact details
Charite - Universitatsmedizin Berlin
Department of Anaesthesiology and Intensive Care Medicine
Campus Charité Mitte and Campus Virchow - Klinikum
Augustenburger Platz 1
Berlin
13353
Germany
-
claudia.spies@charite.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Algorithm-based diagnosis and symptom-orientated treatment of delirium in intensive care unit (ICU)-patients
Acronym
Study hypothesis
Current hypothesis as of 26/06/2015:
Adherence to delirium monitoring as an additional level of care results in an improved clinical outcome.
Secondly we hypothesize that symptom-orientated treatment of delirious deficits results in improved clinical outcome.
Previous hypothesis:
Stepwise symptom-orientated early treatment of predelirium leads to less severity and shorter duration of delirium and better outcome.
On 26/06/2015 the following changes were made to the trial record:
1. The overall trial start date was changed from 01/08/2007 to 01/02/2007
2. The overall trial end date was changed from 31/07/2009 to 31/05/2008
Ethics approval
Local medical ethics committee (Ethikkommission Ethikausschuss 1 am Campus Charité-Mitte), 01/08/2007, ref: EA1/132/07
Study design
Prospective observational monocentre trial
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Screening
Patient information sheet
Condition
Screening for delirium in Intensive Care Unit
Intervention
Current interventions as of 26/06/2015:
Diagnosis and treatment of delirium are made according to internal hospital Standard Operating Procedures. Every patient gets a delirium screening with the use of either the:
1. Delirium Detection Score (DDS), or the
2. Confusion Assessment Method for the ICU.
Data collection in this study will be performed prospectively.. There will be a short analysis of the preliminary data collection from 2006.
Previous interventions:
Diagnosis and treatment of delirium are made according to internal hospital Standard Operating Procedures. Every patient with impaired consciousness gets a delirium screening with the use of two different scoring systems:
1. Delirium Detection Score (DDS)
2. Confusion Assessment Method for the ICU
Ongoing symptom-orientated delirium therapy will be initiated.
Data collection in this study will be performed prospectively. Final analysis of all outcome data will be performed after the anticipated end date of the trial. There will be a short analysis of the preliminary data collection every 6 months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Current primary outcome measures as of 26/06/2015:
1. Mortality
Previous primary outcome measures:
1. Mortality
2. Duration of mechanical ventilation
3. Length of ICU-stay
Secondary outcome measures
Current secondary outcome measures as of 26/06/2015:
1. Incidence of delirium
2. Incidence of hypoactive delirium
3. Incidence of hyperactive delirium
4. Adherence to delirium monitoring
5. Adherence to symptom-orientated treatment of delirium
6. Duration of mechanical ventilation
7. Length of ICU-stay
8. Length of hospital stay
9. Severity of pain
10. Depth of sedation
11. Severity of illness
Previous secondary outcome measures:
1. Higher frequency of delirium detection
2. Higher frequency of hypoactive delirium diagnosis
3. Higher frequency of adequate treatment of delirium
Overall trial start date
01/02/2007
Overall trial end date
31/05/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 26/06/2015:
All patients with an ICU stay greater than 24 hours will be included in this observational trial.
Previous inclusion criteria:
All patients with an ICU stay greater than 36 hours will be included in this observational trial.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant exclusion criteria
Aged less than 18 years.
Recruitment start date
12/02/2007
Recruitment end date
01/11/2007
Locations
Countries of recruitment
Germany
Trial participating centre
Charite - Universitatsmedizin Berlin
Department of Anaesthesiology and Intensive Care Medicine
Campus Charité Mitte and Campus Virchow - Klinikum
Berlin
13353
Germany
Sponsor information
Organisation
Charite - University Medicine Berlin (Universitatsmedizin Berlin) (Germany)
Sponsor details
Chariteplatz 1
Berlin
Berlin
10117
Germany
-
fabian.hempel@charite.de
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Charité Universitätsmedizin Berlin
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list