Contact information
Type
Scientific
Primary contact
Prof Claudia D. Spies
ORCID ID
Contact details
Charite-Universitaetsmedizin Berin
Campus Virchow-Klinikum
Dept. of Anesthesiology and Intensiv Care
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
Web-based program for anti-infective treatment using evidence-based algorithms adapted to local resistance rates
Acronym
Study hypothesis
Hypotheses of this study are: evidence-based anti-infective Standard Operating Procedures (SOPs), adapted to the local resistance rates and to the patient's special risk profile in computerised form:
1. Enhances the adherence rate to SOPs
2. Improves outcome:
2.1. Reduced organ dysfunction, Intensive Care Unit (ICU) stay and mortaliy rates
2.2. Reduces the resistance rates (local rates and national benchmarks)
2.3. Reduces the need (national benchmark) and costs for anti-infectives and the expense for isolation
2.4. Reduces the incidence of Post-Traumatic Stress Disorder (PTSD) after ICU stay (PTSD score)
2.5. Improves the perceived health related quality of life and cost-effectiveness
Ethics approval
Charite - Universitatsmedizin Berlin Ethics Committee, 06/09/2007, ref: EA1/127/07
Study design
Prospective observational study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Critical illness
Intervention
Intended duration: 36 months -
1. 12 months: conversion of the user-accepted SOPs into a web-based version for each participating centre including evidence-based medicine and local resistance rates
2. 12 months: assessment of the implementation rate before and after support by the user-accepted web based versions plus evaluation of the ICU stay and mortality rate with and without SOP adherence
3. 12 months: benchmarking between eight centres and ICU registered national databases for patient outcome and development of resistance rates. Assessment of Health-Related Quality of Life (HRQoL) and Quality-Adjusted Life Years (QALYs) for surviving patients after web-based SOP implementation
Follow up:
The entire duration of the trial is four years, starting January 2006 and ending December 2009.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Implementation rate of SOPs before and after support of web-based computer program
2. Mortality rate with and without adherence to SOPs
Proof of the two primary endpoints in the sense of multiple testing with alpha/2 = 2.5% (Bonferroni's adjustment), i.e., with an error of the first kind of 2.5% each. A drop-out of 10% will be incorporated.
Ongoing outcome measurements in three months intervals including data collection and subsequent three months periods of data interpretation, comparison, and assessment.
Secondary outcome measures
1. Infections with multi-resistant bacteria
2. Beginning and duration of anti-infective therapy
3. Length of infection induced organ failure (ventilator days, Sequential Organ Failure Assessment [SOFA] scores)
4. Duration of ICU treatment including rate of admissions to other ICUs
5. Length of ICU stay
Ongoing outcome measurements in three months intervals including data collection and subsequent three months periods of data interpretation, comparison, and assessment. An exploratory data analysis is planned for the assessment of the secondary outcome measures and risk factor analysis.
Overall trial start date
01/01/2006
Overall trial end date
01/10/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients admitted to five ICUs at Universitaetsmedizin Charite at Campus Mitte and Campus Virchow-Klinikum
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
8000 participants
Participant exclusion criteria
1. Patients under age of 18
2. Length of ICU stay less than 36 hours
3. Non-existing guideline for particular disease
Recruitment start date
01/01/2006
Recruitment end date
01/10/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Charite-Universitaetsmedizin Berin
Berlin
13353
Germany
Sponsor information
Organisation
Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)
Sponsor details
Campus Virchow-Klinikum
Augustenburger Platz 1
Berlin
13383
Germany
-
claudia.spies@charite.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24923469
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25534209