Trial document

PLEASE NOTE:
This trial has been registered retrospectively.

drksid header

DRKS-ID: DRKS00006551

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title

start of 1:1-Block acronym

Trial Acronym

SECRECY

end of 1:1-Block acronym

start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url

start of 1:1-Block public summary

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.

end of 1:1-Block public summary

start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis

start of 1:1-Block forwarded Data

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

end of 1:1-Block forwarded Data

start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content

start of 1:1-Block organizational data

Organizational Data

DRKS-ID: DRKS00006551
Date of Registration in DRKS: 2014/09/29
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 84/14, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg

end of 1:1-Block organizational data

start of 1:n-Block secondary IDs

Secondary IDs

Universal Trial Number (UTN): U1111-1159-9019

end of 1:n-Block secondary IDs

start of 1:N-Block indications

Health Condition or Problem studied

ICD10: T82.7 - Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts

end of 1:N-Block indications

start of 1:N-Block interventions

Interventions/Observational Groups

Arm 1: Evaluation of epidemiological data and risc factors on infections due to central venous catheters (CVC)

end of 1:N-Block interventions

start of 1:1-Block design

Characteristics

Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: Single arm study
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Uncontrolled/Single arm
Purpose: Diagnostic
Assignment: Single (group)
Phase: N/A
Off-label Drug use: N/A

end of 1:1-Block design

start of 1:1-Block primary endpoint

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

end of 1:1-Block primary endpoint

start of 1:1-Block secondary endpoint

Secondary Outcome

Risk factors; germ spectrum; complications

end of 1:1-Block secondary endpoint

start of 1:n-Block recruitment countries

Countries of Recruitment

DE: Germany

end of 1:n-Block recruitment countries

start of 1:n-Block recruitment locations

Locations of Recruitment

University Medical Center Universtitätsklinikum Magdeburg, Klinik für Hämatologie und Onkologie, Magdeburg
University Medical Center Universitätsmedizin Mainz, III. Medizinische Klinik und Poliklinik, Mainz
Medical Center Rotkreuzklinikum München, Abteilung für Innere Medizin III, München
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, 2. Medizinische Klinik - Hämatologie/Internistische Onkologie, Cottbus

end of 1:n-Block recruitment locations

start of 1:1-Block recruitment

Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2013/04/22
Target Sample Size: 3000
Monocenter/Multicenter trial: Multicenter trial
National/International: National

end of 1:1-Block recruitment

start of 1:1-Block inclusion criteria

Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age

end of 1:1-Block inclusion criteria

start of 1:1-Block inclusion criteria add

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

end of 1:1-Block inclusion criteria add

start of 1:1-Block exclusion criteria

Exclusion Criteria

None

end of 1:1-Block exclusion criteria

start of 1:n-Block addresses

Addresses

Primary Sponsor
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Magdeburg
- Leipziger Str. 44
- 39120 Magdeburg
- Germany
end of 1:1-Block address primary-sponsor

start of 1:1-Block address contact primary-sponsor
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.med.uni-magdeburg.de
end of 1:1-Block address contact primary-sponsor
Contact for Scientific Queries
start of 1:1-Block address scientific-contact
- 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-contact

start of 1:1-Block address contact scientific-contact
- Telephone: +49 (0) 391 67 13429
- Fax: 49 (0) 391 67 290315
- E-mail: enrico.schalk at med.ovgu.de
- URL: http://www.khae.ovgu.de/H%C3%A4matologie+und+Onkologie.html
end of 1:1-Block address contact scientific-contact
Contact for Public Queries
start of 1:1-Block address public-contact
- 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-contact

start of 1:1-Block address contact public-contact
- Telephone: +49 (0) 391 67 13147
- Fax: +49 (0) 391 67 290538
- E-mail: christine.friedrichs at med.ovgu.de
- URL: http://www.khae.ovgu.de/H%C3%A4matologie+und+Onkologie.html
end of 1:1-Block address contact public-contact

end of 1:n-Block addresses

start of 1:n-Block material support

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)
start of 1:1-Block address materialSupport
- Universitätsklinikum Magdeburg
- Leipziger Str. 44
- 39120 Magdeburg
- Germany
end of 1:1-Block address materialSupport

start of 1:1-Block address contact materialSupport
- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.med.uni-magdeburg.de
end of 1:1-Block address contact materialSupport

end of 1:n-Block material support

start of 1:1-Block state

Status

Recruitment Status: Recruiting ongoing
Reason, if "Recruitment stopped after recruiting started" or "Recruiting withdrawn before recruting started": [---]*
Reason, if Reason for Recruiting Stop "Other": [---]*
Study Closing (LPLV): [---]*
Number of Participants in Germany after Recruiting complete: [---]*
Total Number of Participants (all Sites worldwide) after Recruiting complete: [---]*

end of 1:1-Block state

start of 1:n-Block publications

Trial Publications, Results and other Documents

Paper: Annals of Hematology
Paper: Infection Control & Hospital Epidemiology
Paper: Infection Control & Hospital Epidemiology
Paper: Infection Control & Hospital Epidemiology
Paper: Infection Control & Hospital Epidemiology
Paper: Infection Control & Hospital Epidemiology
Paper: Infection Control & Hospital Epidemiology

end of 1:n-Block publications

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