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

Augustenburger Platz 1
Berlin
13353
Germany

Study information

Study designProspective observational single centre cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleImplementation 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 acronymDe-Escalation Algorithm
Study objectivesThe 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) studiedVentilator-associated pneumonia
InterventionAfter 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 typeOther
Primary outcome measureNumber of patients with appropriate de-escalation according to VAP algorithm, assessed at the end of data collection.
Secondary outcome measures1. 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 date03/03/2009
Completion date03/03/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants200
Key inclusion criteria1. 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 criteria1. 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 enrolment03/03/2009
Date of final enrolment03/03/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

Augustenburger Platz 1
Berlin
13353
Germany

Sponsor information

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre

Chariteplatz 1
Berlin
10117
Germany

Website http://www.charite.de/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan