Implementation of De-Escalation Algorithm in patients with ventilator-associated pneumonia at two anaesthesiological intensive care units (ICUs) of Charité - University Medicine Berlin
| ISRCTN | ISRCTN80881420 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80881420 |
| Secondary identifying numbers | EA1/209/08 |
- Submission date
- 03/03/2009
- Registration date
- 29/06/2009
- Last edited
- 29/06/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claudia Spies
Scientific
Scientific
Augustenburger Platz 1
Berlin
13353
Germany
Study information
| Study design | Prospective observational single centre cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Implementation of De-Escalation Algorithm in patients with ventilator-associated pneumonia at two anaesthesiological intensive care units (ICUs) of Charité - University Medicine Berlin: a prospective observational single centre trial |
| Study acronym | De-Escalation Algorithm |
| Study objectives | The implementation of evidence-based de-escalation algorithm in ventilator-associated pneumonia (VAP) will increase the rate of appropriate targeted antimicrobial therapy in order to improve patient outcomes. |
| Ethics approval(s) | Ethics Committee of Charité - University Medicine Berlin approved on the 16th February 2009 (ref: EA1/209/08) |
| Health condition(s) or problem(s) studied | Ventilator-associated pneumonia |
| Intervention | After distribution of the de-escalation algorithm, clinician teams will be asked to treat the patients with suspicion of VAP according to algorithm. It will be left to their discretion, whether to adhere to the algorithm in whole or in part or not at all. |
| Intervention type | Other |
| Primary outcome measure | Number of patients with appropriate de-escalation according to VAP algorithm, assessed at the end of data collection. |
| Secondary outcome measures | 1. Number of antibiotic-free days 2. Number of ventilator-free days 3. Number of organ dysfunctions 4. Length of ICU stay 5. Length of hospital stay 6. Rate of super-infections with multidrug resistant (MDR) species (P. aeruginosa, methicillin-resistant S. aureus etc.) 7. Therapy costs All assessed at the end of data collection. |
| Overall study start date | 03/03/2009 |
| Completion date | 03/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Intensive care unit (ICU) patients aged greater than 18 years, either sex 2. On mechanical ventilation for greater than or equal to 48 hours 3. Presenting with systemic inflammatory response syndrome (SIRS) and radiologically suggested new infiltrate |
| Key exclusion criteria | 1. Aged less than 18 years 2. Other unknown infectious focus 3. Severe immune suppression (defined as corticosteroid doses of more than 7.5 mg of prednisolone equivalent for longer than 30 days, or other immuno-suppressive drugs) 4. Acquired immune deficiency syndrome (AIDS)/human immunodeficiency virus (HIV) 5. Moribund patients |
| Date of first enrolment | 03/03/2009 |
| Date of final enrolment | 03/03/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
Augustenburger Platz 1
Berlin
13353
Germany
13353
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Chariteplatz 1
Berlin
10117
Germany
| Website | http://www.charite.de/ |
|---|---|
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Hospital/treatment centre
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
