Condition category
Mental and Behavioural Disorders
Date applied
29/08/2007
Date assigned
18/01/2008
Last edited
26/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes