Study to Evaluate Central venous Catheter-related Infections in Hematology and Oncology
Organizational Data
- DRKS-ID:
- DRKS00006551
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2014-09-29
- Last update in DRKS:
- 2024-02-22
- Registration type:
- Retrospective
Acronym/abbreviation of the study
SECRECY
URL of the study
No Entry
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.
Health condition or problem studied
- ICD10:
- T82.7 - Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- Evaluation of epidemiological data and risc factors on infections due to central venous catheters (CVC)
Endpoints
- 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
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Longitudinal study
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Rotkreuzklinikum München, Abteilung für Innere Medizin III München
- University medical center Universtitätsklinikum Magdeburg, Klinik für Hämatologie und Onkologie Magdeburg
- University medical center Universitätsmedizin Mainz, III. Medizinische Klinik und Poliklinik Mainz
- University medical center Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation Aachen
- University medical center Uniklinik Köln, Klinik für Innere Medizin I - Onkologie, Hämatologie, Klinische Infektiologie, Klinische Immunologie, Hämostaseologie, Internistische Intensivmedizin Köln
- Medical center Carl-Thiem-Klinikum Cottbus, 2. Medizinische Klinik - Hämatologie/Internistische Onkologie Cottbus
- University medical center Johannes Wesling Klinikum Minden, Klinik für Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin Minden
- Medical center Klinikum Mutterhaus Trier, Klinik für Innere Medizin I Trier
- Medical center Klinikum am Bruderwald, Sozialstiftung Bamberg, Medizinische Klinik V Bamberg
- Medical center Klinikum Passau, II. Medizinische Klinik Passau
- Medical center Robert-Bosch-Krankenhaus Stuttgart, Abteilung Hämatologie, Onkologie und Palliativmedizin Stuttgart
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-04-22
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 10000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 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
Primary Sponsor
- Address:
- Universitätsklinikum MagdeburgLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-magdeburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Otto-von-Guericke-Universität MagdeburgMedizinische FakultätZentrum für Innere MedizinKlinik für Hämatologie und OnkologiePriv.-Doz. Dr. med. habil. Enrico SchalkLeipziger Straße 4439120 MagdeburgGermany
- Telephone:
- +49 (0) 391 67 13429
- Fax:
- 49 (0) 391 67 290315
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.khae.ovgu.de/H%C3%A4matologie+und+Onkologie.html
Contact for Public Queries
- Address:
- Universitätsklinikum Magdeburg A.ö.R., Klinik für Hämatologie und Onkologie, StudiensekretariatChristine FriedrichsLeipziger Straße 4439120 MagdeburgGermany
- Telephone:
- +49 (0) 391 67 13134
- Fax:
- +49 (0) 391 67 290538
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.khae.ovgu.de/H%C3%A4matologie+und+Onkologie.html
Principal Investigator
- Address:
- Otto-von-Guericke-Universität MagdeburgMedizinische FakultätZentrum für Innere MedizinKlinik für Hämatologie und OnkologiePriv.-Doz. Dr. med. habil. Enrico SchalkLeipziger Straße 4439120 MagdeburgGermany
- Telephone:
- +49 (0) 391 67 13429
- Fax:
- 49 (0) 391 67 290315
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.khae.ovgu.de/H%C3%A4matologie+und+Onkologie.html
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum MagdeburgLeipziger Str. 4439120 MagdeburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-magdeburg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.Leipziger Str. 44 Haus 2839120 MagdeburgGermany
- Telephone:
- +49-391-6714314
- Fax:
- +49-391-67290185
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-05-27
- Ethics committee number:
- 84/14
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-07-23
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- 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;94(9):1451-6. doi: 10.1007/s00277-015-2387-y.
- Schalk E, Färber J, Fischer T, Heidel FH. Central Venous Catheter-Related Bloodstream Infections in Obese Hematologic Patients. Infect Control Hosp Epidemiol 2015;36(8):995-6. doi: 10.1017/ice.2015.107
- Schalk E, Fischer T. Biased Low Incidence of Central Venous Catheter-Related Bloodstream Infections in Controlled Clinical Trials? Infect Control Hosp Epidemiol 2016;37(5):617-9. doi: 10.1017/ice.2016.36
- Schalk E, Biehl LM, Färber J, Schlüter D, Vehreschild MJGT, Fischer T. Determination of a Cutoff Time Point for Prophlactic Exchange of Central Venous Catheters for Prevention of Central Venous Catheter-Related Bloodstream Infections in Patients with Hematological Malignancies. Infect Control Hosp Epidemiol 2017;38(7):888-889. doi: 10.1017/ice.2017.92
- 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;40(10):1204-1206. doi: 10.1017/ice.2019.224
- 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;41(2):254-256. doi: 10.1017/ice.2019.335
- 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 2022;43(12):1953-1955. doi: 10.1017/ice.2021.491
- Schalk E, Hentrich. M Real-World Data. Dtsch Arztebl Int 2022;119(8):134. doi: 10.3238/arztebl.m2022.0035
- Schalk E, Biehl LM, Böll B. Jugular vein inserted central venous catheters (CVC) and the risk of CVC-related bloodstream infections in patients with hematological malignancies. Am J Hematol 2022;97(9):E336-E340. doi: 10.1002/ajh.26633
- Panse J, Tölle D, Fiegle E, Naendrup JH, Schmidt-Hieber M, Böll B, Hentrich M, Teschner D, Schalk E. Scheduled removal of central venous catheters (CVC) to prevent CVC-related bloodstream infections in patients with hematological disease or autologous stem cell transplantation: A registry-based randomized simulation-study. Ann Hematol 2022;101(10):2317-2324. doi: 10.1007/s00277-022-04958-w
- Schalk E, Schmitt T, Panse J, Fiegle E, Naendrup JH, Schmidt-Hieber M, Böll B, Hentrich M, Teschner T, Mougiakakos D. Central venous catheter-related bloodstream infections in patients with haematological malignancies during the SARS-CoV-2 pandemic. Br J Haematol 2022;199(4):e16-e20. doi: 10.1111/bjh.18442
- Hentrich M, Böll B, Teschner D, Panse J, Schmitt T, Naendrup JH, Schmidt-Hieber M, Neitz J, Fiegle E, Schalk E. Impact of the insertion site of central venous catheters on central venous catheter-related bloodstream infections in patients with cancer: results from a large prospective registry. Infection 2023;51(4):1153-1159. doi: 10.1007/s15010-023-02029-4
- Teschner D, Berisha M, Panse J, Schmitt T, Fiegle E, Naendrup JH, Neitz J, Schmidt-Hieber M, Hentrich M, Böll B, Schalk E. Chlorhexidine gluconate-coated gel pad dressings for prevention of central venous catheter-related bloodstream infections in patients with hematologic diseases or autologous stem cell transplantation: A registry-based matched-pair analysis. Eur J Haematol 2023; doi: 10.1111/ejh.14098
- Schalk E, Panse J. Which trial do we need? Scheduled central venous catheter removal vs. routine clinical care for prevention of central venous catheter-related bloodstream infections in patients with haematologic malignancies. Clin Microbiol Infect 2023;29(4):417-418. doi: 10.1016/j.cmi.2023.01.003
- Date of first publication of study results:
- 2015-05-03
- DRKS entry published for the first time with results:
- 2015-05-04
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry