Trial document




This trial has been registered retrospectively.
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  DRKS00006551

Trial Description

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Title

Study to Evaluate Central venous Catheter-related Infections in Hematology and Oncology

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Trial Acronym

SECRECY

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URL of the Trial

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Brief Summary in Lay Language

Central venous catheter-related infections are a frequent problem in hematolgoy and oncology. Due to different definitions of such infections, because there are many different institutions and medical scocieties, it is difficult to compare data regarding these infections. In 2014, the Infectious Diseases Working Party of the German Society of Hematology and Medical Oncology has revised the definitions. Epidemiological data based on these current definitions are not available so far. Therefore, in this registry epidemiological data and risk factors for these infections will be documented. Furthermore, using the Infecious Probability Score prediction of these infections will be made.

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Brief Summary in Scientific Language

Central venous catheters (CVC) are widely used in hematology and oncology. Cancer patients, by different risk factors are at high risk in terms of CVC infections (catheter-related infections, CRI), associated with increased morbidity, mortality, and hospital costs. The diagnosis of CRI is based on clinical symptoms and laboratory constellations that can withstand not always clear definitions. In the literature, there are different definitions of CRI published by different institutions and medical societies. The risk of infection varies between catheter type, insertion site, immunocompetence, number of days of CVC in use and other factors. The Infectious Diseases Working Party (AGIHO) of the German Society of Hematology and Medical Oncology (DGHO), had created CRI definitions that are consistent with international medical societies as well as easy to use in the clinic. The AGIHO distinguishes between definite, probable and possible catheter-related blood stream infections (CRBSI). Due to different definitions, different not clearly comparable epidemiological data on CVC infections exist. Epidemiological data based on the current AGIHO criteria (2014), have not yet been generated or published. One objective is therefore to generate these epidemiological data by a prospective observational study. Since the diagnosis of CVC infections can often be made only when the CVC has already been removed, the question arises whether there is a symptom or parameter constellation that could indicate or exclude such infection. With the Infection Probability Score (IPS), the presence or absence of infections can be predicted in critically ill patients. For the IPS the simply and widely used parameters body temperature, heart rate, blood pressure, leukocytes, C-reactive protein and parameters of the Sequential Organ Failure Assessment (SOFA) score are used. A score of 14 was determined as cut-off. Patients who had a score <14 have a risk of 10% only for infection [negative predictive value (NPV) = 90%]. Using the IPS, infections can be excluded with high probability. In the following, the IPS was examined in various, mostly intensive care scenarios. Specifically on the issue of CVC infections using the IPS, there are still no published data.
This study is a non-interventional, prospective observational/cohort study. As cohort was defined all patients, who were treated in the Department of Hematology and Oncology receiving a CVC for treatment of any kind. Through this observation study, the following questions are answered and the following data are generated: calculation of prevalence and incidence of CRBSI according to the current AGIHO definitions (with differentiation in definite, probable and possible CRBSI); identification of risk factors that favor CVC infections; application of the IPS and calculating a cut-off for the detection/exclusion of CRBSI; documentation of the germ spectrum, which led to CRBSI; documentation of complications of CVC insertion as well as in the course of use.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006551
  •   2014/09/29
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  •   yes
  •   Approved
  •   84/14, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1159-9019 
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Health Condition or Problem studied

  •   T82.7 -  Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts
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Interventions/Observational Groups

  •   Evaluation of epidemiological data and risc factors on infections due to central venous catheters (CVC)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Prevalence and incidence of CVC infections (CRBSI, catheter-related bloodstream infections) in hematology and oncology (using the AGIHO/DGHO 2014 criteria); using the Infection Probability Score (IPS) and determine a cut-off value for CVC infection

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Secondary Outcome

Risk factors; germ spectrum; complications

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • Medical Center 
  • University Medical Center 
  • University Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2013/04/22
  •   3000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

In-patient therapy in the Department of Hematology and Oncology; indication for CVC insertion for therapeutic itention; informed consent for CVC insertion for therapeutic intenion

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Exclusion Criteria

None

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Addresses

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Otto-von-Guericke-Universität MagdeburgMedizinische FakultätZentrum für Innere MedizinKlinik für Hämatologie und Onkologie
    • Mr.  Dr. med.  Enrico  Schalk 
    • Leipziger Straße 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinikum Magdeburg A.ö.R.Klinik für Hämatologie und OnkologieStudiensekretariat
    • Ms.  Christine  Friedrichs 
    • Leipziger Straße 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Magdeburg
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.