Trial document




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  DRKS00017593

Trial Description

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Title

Feasibility study of a mobile device for the prevention of sepsis in patients with solid tumors after chemotherapy

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Patients with advanced stages of solid tumors rely on an interdisciplinary therapy. These include peri-interventional chemotherapy and radiation, as well as palliative chemotherapy in the metastatic state.
The side effect of these therapeutic approaches are sometimes serious. The most common side effects include nausea, fatigue and diarrhea. In addition, there are also delayed, life-threatening side effects due to the toxic effect on the bone marrow after intensive chemotherapies. During chemotherapy there may be a drop in leucocytes in the blood. The leukocytes are part of the immune defense and essential for controlling infectious diseases.
Due to the immunosuppression of patients, it is significantly more common to severe infections than in the normal population. In addition, the seotic course of diseases show more often a fatal outcome.
A sepsis can already be detected clinically early by simply measuring certain vital parameters such as blood pressure, pulse rate and temperature. The mortality of the septic patient depends on the time to antibiotic therapy. The mortality increases with each hour of late antibiotic administration by about 7%. Despite good treatment information about side effects, patients with a septic constellation will not present themselves to the clinic until hours or days after the onset of symptoms. Early detection and intervention by medical staff would therefore be desirable and could potentially affect mortality and hospitalization time.
Due to the rapid development of information technology, mobile devices have been developed in recent years that meet all the requirements for measuring the most important vital signs in real time. Through software analysis, potential risk constellations can be identified.
The study is therefore investigating the use, data collection and data transmission of a mobile device for sepsis prevention in patients with solid tumors undergoing chemotherapy.

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Brief Summary in Scientific Language

Patients with advanced stages of solid tumors rely on an interdisciplinary therapy. These include peri-interventional chemotherapy and radiation, as well as palliative chemotherapy in the metastatic state.
The side effect of these therapeutic approaches are sometimes serious. The most common side effects include nausea, fatigue and diarrhea. In addition, there are also delayed, life-threatening side effects due to the toxic effect on the bone marrow after intensive chemotherapies. During chemotherapy there may be a drop in leucocytes in the blood. The leukocytes are part of the immune defense and essential for controlling infectious diseases.
Due to the immunosuppression of patients, it is significantly more common to severe infections than in the normal population. In addition, the seotic course of diseases show more often a fatal outcome.
A sepsis can already be detected clinically early by simply measuring certain vital parameters such as blood pressure, pulse rate and temperature. The mortality of the septic patient depends on the time to antibiotic therapy. The mortality increases with each hour of late antibiotic administration by about 7%. Despite good treatment information about side effects, patients with a septic constellation will not present themselves to the clinic until hours or days after the onset of symptoms. Early detection and intervention by medical staff would therefore be desirable and could potentially affect mortality and hospitalization time.
Due to the rapid development of information technology, mobile devices have been developed in recent years that meet all the requirements for measuring the most important vital signs in real time. Through software analysis, potential risk constellations can be identified.
The study is therefore investigating the use, data collection and data transmission of a mobile device for sepsis prevention in patients with solid tumors undergoing chemotherapy.

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Organizational Data

  •   DRKS00017593
  •   2019/07/26
  •   [---]*
  •   yes
  •   Approved
  •   FF 136/2018, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   C00
  •   C00-C75 -  Malignant neoplasms, stated or presumed to be primary, of specified sites, except of lymphoid, haematopoietic and related tissue
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Interventions/Observational Groups

  •   5 days after chemotherapy, patients receive a VitalPatch to record the vital signs. The collected data will be evaluated after return of the product. In addition, the patient is interviewed regarding complications and technical problems.
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Characteristics

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

Pilot study on the feasibility and application of a mobile device on a patient collective. There is no primary endpoint because it is a pilot study.

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Secondary Outcome

Sepsis prevention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2019/08/02
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients with solid tumors and planned chemotherapy

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Exclusion Criteria

younger than 18 years
older than 99 years
Not able to sign informed consent

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Addresses

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    • Sana Klinikum Offenbach
    • Mr.  Dr. med.  Mate  Knabe 
    • Starkenburgring 66
    • 63069  Offenbach am Main
    • Germany
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    • Sana Klinikum Offenbach
    • Mr.  Dr. med.  Mate  Knabe 
    • Starkenburgring 66
    • 63069  Offenbach am Main
    • Germany
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    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
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    • Sana Klinikum Offenbach
    • Mr.  Dr. med.  Mate  Knabe 
    • Starkenburgring 66
    • 63069  Offenbach am Main
    • Germany
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Sources of Monetary or Material Support

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    • Sana Klinikum Offenbach
    • Mr.  Dr. med.  Mate  Knabe 
    • Starkenburgring 66
    • 63069  Offenbach am Main
    • Germany
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    • HMS Analytical Software GmbH
    • Mr.  Nicolai  Henrichs 
    • Rohrbacher Str. 26
    • 69115  Heidelberg
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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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.