Condition category
Signs and Symptoms
Date applied
17/08/2007
Date assigned
04/10/2007
Last edited
22/07/2015
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 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 measures

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

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

http://www.charite.de/

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24923469
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25534209

Publication citations

Additional files

Editorial Notes