Algorithm-based diagnosis and symptom-orientated treatment of delirium in intensive care unit (ICU)-patients

ISRCTN	ISRCTN76100795
DOI	https://doi.org/10.1186/ISRCTN76100795
Protocol serial number	N/A
Sponsor	Charite - University Medicine Berlin (Universitatsmedizin Berlin) (Germany)
Funder	Charité Universitätsmedizin Berlin

Submission date: 29/08/2007
Registration date: 18/01/2008
Last edited: 12/05/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Claudia Spies
Scientific

Charite - Universitatsmedizin Berlin
Department of Anaesthesiology and Intensive Care Medicine
Campus Charité Mitte and Campus Virchow - Klinikum
Augustenburger Platz 1
Berlin
13353
Germany

Email	claudia.spies@charite.de

Study information

Primary study design	Observational
Study design	Prospective observational monocentre trial
Secondary study design	Cohort study
Scientific title	Algorithm-based diagnosis and symptom-orientated treatment of delirium in intensive care unit (ICU)-patients
Study objectives	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(s)	Local medical ethics committee (Ethikkommission Ethikausschuss 1 am Campus Charité-Mitte), 01/08/2007, ref: EA1/132/07
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	31/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	185
Total final enrolment	185
Key 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.
Key exclusion criteria	Aged less than 18 years.
Date of first enrolment	01/07/2007
Date of final enrolment	01/11/2007

Locations

Countries of recruitment

Germany

Study participating centre

Charite - Universitatsmedizin Berlin

Department of Anaesthesiology and Intensive Care Medicine
Campus Charité Mitte and Campus Virchow - Klinikum
Berlin
13353
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available due to legal restrictions imposed by the Ethics Commission of the Charité – Universitätsmedizin Berlin and the data protection commissioner of the Charité – Universitätsmedizin Berlin, public sharing of study data with other researchers or entities is not allowed. This prohibits the authors from making the dataset publicly available.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/10/2016	12/05/2021	Yes	No

Editorial Notes

12/05/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 12/02/2007 to 01/07/2007.
2. The target number of participants was changed from 1000 to 185.
3. Total final enrolment number, publication reference and IPD sharing statement added.