Trial document





This trial has been registered retrospectively.
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  DRKS00004278

Trial Description

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Title

Characterisation of neuropsychological and motoric performance in patients with hyponatremia

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Hyponatremia is the most common electrolyte disorder in outpatients and hospitalized patients. Especially mild to moderate hyponatremia without apparent symptoms has seldomly been accurately assessed but rather seen as clinically irrelevant. Newer studies revealed an association between mild hyponatremia and unstable walking, frequency of falls and risk of a fracture. Until now, there is no known detailed investigation and characterisation of the cognitive and motoric performance or limitation by this disorder. Therefore this study will investigate patients with hyponatremia on the basis of neuropsychological and neurological tests.

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Brief Summary in Scientific Language

Hyponatremia is a common electrolyte disorder. Severe hyponatremia is associated with seizures, lethargy and confusion whereas mild hyponatremia has been regarded as mainly asymptomatic. Latest studies revealed that even mild hyponatremia is associated with gait disorders, increased risk for falls and fractures.
Even though sypmtoms of mild hyonatremia are subtle and at first glance clinically not relevant they may have a significant impact on daily life such as wrong drug intake due to attention deficits and falls due to gait disturbances. The aim of this study is characterization of cognitive and motoric deficits as well as mental symptoms in hyponatremic patients.

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Organizational Data

  •   DRKS00004278
  •   2012/08/09
  •   [---]*
  •   yes
  •   Approved
  •   12-060, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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

  •   E87.1 -  Hypo-osmolality and hyponatraemia
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Interventions/Observational Groups

  •   Neuropsychological and motoric tests
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Characteristics

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

Patients score in the following neuropsychological and motoric tests during phase of hyponatremia (< 130 mmol/l) and after at least 48 hours. Dem-Tect- signs of dementia; MMST- cognitive deficits; Trail-Making-Test- psychomotoric speed and executive functions; BDI-V- signs of depression; Timed-up and go- motoric deficits.

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Secondary Outcome

Quality of life SF-36
during phase of hyponatremia (< 130 mmol/l) and after increase of serum sodium > 10 mmol/l or normalization of serum sodium level after at least 48 hours

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/06/19
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

1. Men and women of 18 years of age or older
2. Hyponatremia with serum sodium < 130 mmol/l

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Exclusion Criteria

1. traumatic cerebral injury, hemorrhagic and ischemic insult as cause of hyponatremia
2. professional or private relationship between subject and the investigators or dependance on the investigators
3. Placement in an institution based on official orders
4. Patients who are incapable of giving informed consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität zu Köln
    • Mr.  Dr.  Volker  Burst 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Universität zu Köln
    • Mr.  Dr.  Volker  Burst 
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Universitätsklinikum Köln (AöR) Klinik II für Nephrologie
    • Ms.  Cornelia  Böhme 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Köln
    • Kerpener Str. 62
    • 50924  Köln
    • 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.