An interventional study of Change Management in Sepsis and Shock, Septic, sponsored by Center for Sepsis Control and Care, Germany. Completed at 42 sites in Germany. Per ClinicalTrials.gov, last updated 2017-08-09.
Sponsored by Center for Sepsis Control and Care, Germany · Not applicable, Interventional, and Other
Patients with severe sepsis or septic shock suffer from life-threatening infections. Fast and adequate therapy with antibiotics is crucial for survival. Current guidelines recommend the application of broad-spectrum antibiotics within 1 hour after diagnosis. However, recent studies showed that such treatment is delayed for several hours.
In this study, medical staff of participating hospitals is trained to achieve a duration until antimicrobial therapy of less than 1 hour. Tools of change management are used. The data are compared to a control group (hospitals without intervention).
It is hypothesized that a multifaceted educational program decreases duration until antimicrobial therapy and improves survival.
This study is a cluster randomized trial (CRT) where the hospitals are the clusters. 44 hospitals in Germany have confirmed their participation. Hospitals are randomized into two groups: a control and an interventional group. The control group receives conventional CMEs. The interventional group receives tools for increasing awareness such as posters and brochures. Quality measure such as benchmarking and feedback of quality indicators are used. Depending on the improvement process tools such as SWOT analyses and resistance radar will be implemented.
The CRT was preceded by a 5 months observational study (Dec. 2010 - April 2011). In about 1000 patients, participating hospitals documented their patients with severe sepsis or septic shock into a register. These data are used for final sample size calculation of the CRT and for stratification of the randomization.
The groups switch after completion of the CRT and observation continues. Thus, centers of the control group now receive the change management while the former intervention group is now without external support and is assessed for sustainability of the intervention. This study phase is planned for Nov. 2013 until March 2015. Sample size will be calculated when the CRT has been finished.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 4,138 is above the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Center for Sepsis Control and Care, Germany is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
For the hospitals (cluster):
For the patients:
New onset of suspicion of severe sepsis or septic shock in the following settings:
Exclusion Criteria:
For the hospitals (cluster):
For the patients:
Behavioral: Change Management
Hospitals receive conventional continuing medical education in lecture style twice a year. They receive current publications and recommendations for national and international meetings regarding diagnosis and therapy of sepsis.
Hospitals have to create local change teams which are supported and trained by the study center. Local awareness of the staff is increased by PowerPoint presentations, posters, and brochures. The change teams receive monthly information about their quality indicator (duration until antimicrobial therapy). Anonymous comparison to other hospitals is possible (Benchmarking). Hospitals are visited three times a year to discuss progress of quality. In case of failure to improve, the change team is supported with specific tools for change management such as SWOT-analysis or resistance radar.
All-cause mortality
Time frame: 28 days
Fraction of patients with antimicrobial therapy within 1 hour
Duration until antimicrobial therapy
Duration until focus control
Frequency of blood cultures
Frequency of adequate antimicrobial therapy
ICU and hospital mortality
ICU and and hospital length of stay
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Center for Sepsis Control and Care, Germany