Trial document
This trial has been registered retrospectively.
DRKS00006551
Trial Description
Title
Study to Evaluate Central venous Catheter-related Infections in Hematology and Oncology
Trial Acronym
SECRECY
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.
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.
Do you plan to share individual participant data with other researchers?
No
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
Secondary IDs
- U1111-1159-9019
Health Condition or Problem studied
- T82.7 - Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts
Interventions/Observational Groups
- Evaluation of epidemiological data and risc factors on infections due to central venous catheters (CVC)
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
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
Secondary Outcome
Risk factors; germ spectrum; complications
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
- University Medical Center
- Medical Center
- University Medical Center
- University Medical Center
- Medical Center
Recruitment
- Actual
- 2013/04/22
- 3000
- Multicenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
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
Exclusion Criteria
None
Addresses
-
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- Universitätsklinikum Magdeburg
- Leipziger Str. 44
- 39120 Magdeburg
- Germany
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- http://www.med.uni-magdeburg.de
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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
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 (0) 391 67 13429
- 49 (0) 391 67 290315
- enrico.schalk at med.ovgu.de
- http://www.khae.ovgu.de/H%C3%A4matologie+und+Onkologie.html
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- Universitätsklinikum Magdeburg A.ö.R.Klinik für Hämatologie und OnkologieStudiensekretariat
- Ms. Christine Friedrichs
- Leipziger Straße 44
- 39120 Magdeburg
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 (0) 391 67 13147
- +49 (0) 391 67 290538
- christine.friedrichs at med.ovgu.de
- http://www.khae.ovgu.de/H%C3%A4matologie+und+Onkologie.html
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universitätsklinikum Magdeburg
- Leipziger Str. 44
- 39120 Magdeburg
- Germany
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- http://www.med.uni-magdeburg.de
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
- Schalk E, Hanus L, Färber J, Fischer T, Heidel FH. Prediction of central venous catheter-related bloodstream infections (CRBSIs) in patients with haematologic malignancies using a modified Infection Probability Score (mIPS). Ann Hematol. 2015 Sep;94(9):1451-6. doi: 10.1007/s00277-015-2387-y. Epub 2015 May 3. PMID: 25933677.
- Schalk E, Färber J, Fischer T, Heidel FH. Central Venous Catheter-Related Bloodstream Infections in Obese Hematologic Patients. Infect Control Hosp Epidemiol. 2015 Aug;36(8):995-6. doi: 10.1017/ice.2015.107. Epub 2015 May 20. PMID: 25990462.
- Schalk E, Fischer T. Biased Low Incidence of Central Venous Catheter-Related Bloodstream Infections in Controlled Clinical Trials? Infect Control Hosp Epidemiol. 2016 May;37(5):617-9. doi: 10.1017/ice.2016.36. Epub 2016 Feb 26. PMID: 26916270.
- Schalk E, Biehl LM, Färber J, Schlüter D, Vehreschild MJGT, Fischer T. Determination of a Cutoff Time Point for Prophylactic Exchange of Central Venous Catheters for Prevention of Central Venous Catheter-Related Bloodstream Infections in Patients with Hematological Malignancies. Infect Control Hosp Epidemiol. 2017 Jul;38(7):888-889. doi: 10.1017/ice.2017.92. Epub 2017 May 18. PMID: 28514979.
- Tölle D, Hentrich M, Pelzer BW, Kremer P, Einhell S, Schulz S, Böll B, Panse J, Schmidt-Hieber M, Teschner D, Schalk E. Impact of neutropenia on central venous catheter-related bloodstream infections in patients with hematological malignancies at the time of central venous catheter insertion: A matched-pair analysis. Infect Control Hosp Epidemiol. 2019 Oct;40(10):1204-1206. doi: 10.1017/ice.2019.224. Epub 2019 Jul 29. PMID: 31352911.
- Schalk E, Teschner D, Hentrich M, Böll B, Panse J, Schmidt-Hieber M, Vehreschild MJGT, Biehl LM. Central venous catheter-related bloodstream infections in patients with hematological malignancies: Comparison of data from a clinical registry and a randomized controlled trial. Infect Control Hosp Epidemiol. 2020 Feb;41(2):254-256. doi: 10.1017/ice.2019.335. PMID: 31818338.
- Schalk E, Hentrich M. Overweight or obesity are not risk factors for central venous catheter-related bloodstream infections in patients with hematological malignancies. Infect Control Hosp Epidemiol. 2021 Dec 20:1-3. doi: 10.1017/ice.2021.491. Epub ahead of print. PMID: 34924070.
- Schalk E, Hentrich M Real-World Data. Dtsch Arztebl Int. 2022 Feb 25;119(8):134. doi: 10.3238/arztebl.m2022.0035. PMID: 35506295