Trial document




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  DRKS00000400

Trial Description

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Title

Gro-alpha and MCP-1 as potential markers for preoperative identification of old patients with hip fractures at risk for developing complications after surgery.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The hip fracture is a typical fracture of the old patient. the overaging of our society leads to an increase of patients suffering from hip fractures. Unfortunately, these patients often develop complications like urinary tract infections, pneumonia or wound infections after surgery. Fot the old patient this means a prolonged in-hospital stay or problems with mobilisation up to loss of autonomy.
As the immune system changes in the course of life its function is altered in the old patient as well. Several investigations could show that there are two markers (Gro-alpha and MCP-1), which play an important role in inflammation and immune system function. These markers were expressed differently in patients suffering from postoperative complications compared to patients without complications. Thererfore, aim of this study is to analyse whether these two markers are suitable predicitve markers for postoperative complications in old patients with hip fractures.

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Brief Summary in Scientific Language

In spite of medical progress, the hip fracture still has a post operative complication rate of 26,1%, an in-hospital mortality rate of 6,6% and a 1-year mortality rate of 30 %. This is due to a immune system dysfunction in the elderly patient. Because of our growing old population, the incidence of hip fractures in the year 2050 will be more than double. Therefore, medical problems concerning this group of patients are highly important. Up to now, the parameters and pathways involved in the systemic inflammation still remain elusive. As not all of the patients suffer from postoperative complications, the susceptibility to developing complications seems to be an individual problem. The identification of patients at risk for postoperative complications could give the clinician the possibility of taking early actions. This could help minimizing complications and tragic courses. Presutdies could show that MCP-1 and GRO-alpha were expressed differently in patients suffering from complications compared to the ones without problems. As these chemokines are responsible for monocyte and granulocyte activation, a misregulation of these factors could be a potential reason for the posttraumatic immune system dysfunction of the old patient. Therefore, aim of this study is to analyse the role of MCP-1 and GRO-alpha in the posttraumatic immune system dysfunction of the old patient with hip fracture.

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

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00000400
  •   2010/05/07
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  •   yes
  •   Approved
  •   2783/10, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  •   U1111-1114-8069 
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Health Condition or Problem studied

  •   S72.00 -  [generalization S72.0: Fracture of neck of femur]
  •   hip fracture
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Interventions/Observational Groups

  •   Blood samples of 36 ml blood are taken from patients pre operativey and within 12 hours after surgery.
  •   A blood sample of 36 ml is taken once from the probands.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
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Primary Outcome

Expression levels of GRO- alpha and MCP-1 in the serum of patients older than 75 years with a hip fracture and with or without postoperative complications. These expression levels are analysed in the serum of blood sampley taken pre- and postoperatively. Complications are detected during the in-hospital stay of the patients.

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Secondary Outcome

Analysis of transcription factors (STAT, JNK) in granulocytes and monocytes.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2010/10/01
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

inclusion criteria for the patients:
-older than 75 years for group 1 and for group 2 older than 18 years and younger than 40 years
-informed consent
- hip fracture (group1) and fracture of a long bone (group2) respectively

inclusion criteria for the probands:
- older than 75 years for group 1 and for group 2 older than 18 years and younger than 40 years
- informed consent
- no fracture within the last twelve weeks

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Exclusion Criteria

exclusion criteria for the patients and probands
- younger than 18 years
- pregnancy
-open fractures
-periprothetic fractures
-polytrauma
-patients with systemic infection diseases
-tumours, radiochemotherapy
-intake of drugs which could modulate the immune system like corticosteroids
-patients/probands who cannot give their informed consent

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Addresses

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    • Klinikum rechts der Isar, Technische Universität München
    • Ismaningerstrasse 22
    • 81675  München
    • Germany
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    • Klinikum rechts der Isar, Abteilung für Unfallchirurgie, Technische Universität München
    • Ms.  Dr. med.  Helen  Vester 
    • Abteilung für Unfallchirurgie, Ismaningerstrasse 22
    • 81675  München
    • Germany
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    • Klinikum rechts der Isar, Abteilung für Unfallchirurgie, Technische Universität München
    • Ms.  Dr. med.  Helen  Vester 
    • Ismaningerstrasse 22
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • DFG
    • Kennedyallee
    • 53170  Bonn
    • 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.