Trial document





This trial has been registered retrospectively.
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  DRKS00004413

Trial Description

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Title

Time-course of CNS cytokine concentrations after elective orthopedic procedures in the elderly and their possible role as biomarkers for delirium

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Delirium is a serious complication in older hospitalized patients that is associated with an increased risk of death, institutionalization and dementia after discharge.
The question which patient will suffer from delirium and what is happening in that patient's body is not finally cleared. One idea is that neuroinflammation contributes to the development of delirium.
Aim of the project is to investigate circulating cytokines (as a marker of inflammation) in blood and cerebrospinal fluid of patients who will hopefully not suffer from delirium, in order to present a baseline of these markers to allow identifying patients at risk in the future.

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Brief Summary in Scientific Language

Delirium is a serious coomplication in older hospitalized patients that is associated with an increased risk of death, institutionalization and dementia after discharge. Current evidence suggests that neuroinflammation contributes to its development. Since levels of circulating cytokines not adequately mirror the CNS inflammatory process, levels in cerebrospinal fluid should be determined. No baseline data on cytokine concentrations and its time-course in the mentally healthy elderly is known yet. Aim of the project is to investigate the time-course of CNS and peripheral blood cytokine concentrations before and after elective major orthopedic surgery. Ultimately, the project might have an implication on the development of more effective approaches to identify patients at risk for postoperative delirium in the future.

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Organizational Data

  •   DRKS00004413
  •   2012/10/04
  •   [---]*
  •   yes
  •   Approved
  •   2009-167-f-S, Ethik-Kommission der Ärztekammer Westfalen-Lippe und der med. Fakultät der Westfälischen Wilhelms-Universität Münster
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F05.0 -  Delirium not superimposed on dementia, so described
  •   F05.1 -  Delirium superimposed on dementia
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Interventions/Observational Groups

  •   Patients with elective major orthopedic surgery (hip replacement); preoperatively: Mini Mental Status Test (MMMST), Confusion Assessment Method (CAM). Postoperatively: CAM (twice a day). At all three times CSF and blood samples.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Time-course of cytokine concentrations in CSF and blood (before surgery and on first and second day post OP)

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Secondary Outcome

Delirium; further postoperative complications; death; lung emboly; pain; heart failure; apoplexia. Routine examinations of blood, visual analogue scale (VAS - twice a day - pain) and Confusion Assessment Method (CAM - twice a day - delirium)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/06/10
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

elective major orthopedic surgery (hip replacement); normal preoperative scores in MMST; normal preoperative scores in CAM

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Exclusion Criteria

non-elective surgery; MMST or IQCODE or CAM indicating cognitive impairment or preexisting delirium

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Addresses

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    • Klinik für Anästhesie und operative Intensivmedizin, St. Franziskus-Hospital Münster
    • Ms.  Dr. med.  Simone  Gurlit 
    • Hohenzollernring 72
    • 48145  Münster
    • Germany
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    • Klinik für Anästhesie und operative Intensivmedizin St. Franziskus-Hospital Münster
    • Ms.  Dr. med.  Simone  Gurlit 
    • Hohenzollernring 72
    • 48145  Münster
    • Germany
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    • St. Franziskus-Hospital Münster Klinik für Anästhesie und operative Intensivmediizin
    • Ms.  Dr. med.  Simone  Gurlit 
    • Hohenzollernring 72
    • 48145  Münster
    • Germany
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Sources of Monetary or Material Support

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    • Forschungskolleg Geriatrie Robert Bosch Stiftung
    • Heidehofstr. 31
    • 70184  Stuttgart
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.