Algorithm-based diagnosis and symptom-orientated treatment of delirium in intensive care unit (ICU)-patients
| ISRCTN | ISRCTN76100795 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76100795 |
| Secondary identifying numbers | N/A |
- 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
Scientific
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 |
Study information
| Study design | Prospective observational monocentre trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| 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 | 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 study start date | 01/02/2007 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Campus Charité Mitte and Campus Virchow - Klinikum
Berlin
13353
Germany
Sponsor information
Charite - University Medicine Berlin (Universitatsmedizin Berlin) (Germany)
University/education
University/education
Chariteplatz 1
Berlin
Berlin
10117
Germany
| fabian.hempel@charite.de | |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
University/education
Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medical School - Charité - University Medicine Berlin
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Not provided at time of registration |
| 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.
