Web-based program for anti-infective treatment using evidence-based algorithms adapted to local resistance rates

Not Applicable

Completed

• Conditions: Critical illness; Signs and Symptoms

• Registration Number: ISRCTN54598675
• Lead Sponsor: Charite - University Medicine Berlin (Charite - Universitatsmedizin Berlin) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-04
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

All patients admitted to five ICUs at Universitaetsmedizin Charite at Campus Mitte and Campus Virchow-Klinikum

Exclusion Criteria

1. Patients under age of 18
2. Length of ICU stay less than 36 hours
3. Non-existing guideline for particular disease

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Implementation rate of SOPs before and after support of web-based computer program<br>2. Mortality rate with and without adherence to SOPs<br><br>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.<br><br>Ongoing outcome measurements in three months intervals including data collection and subsequent three months periods of data interpretation, comparison, and assessment.

Secondary Outcome Measures

Name	Time	Method
1. Infections with multi-resistant bacteria<br>2. Beginning and duration of anti-infective therapy<br>3. Length of infection induced organ failure (ventilator days, Sequential Organ Failure Assessment [SOFA] scores)<br>4. Duration of ICU treatment including rate of admissions to other ICUs<br>5. Length of ICU stay<br><br>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.