<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02242604</url>
  </required_header>
  <id_info>
    <org_study_id>V1.1</org_study_id>
    <secondary_id>DRKS00005776</secondary_id>
    <nct_id>NCT02242604</nct_id>
  </id_info>
  <brief_title>Characterization of Neuropsychologic and Physical Performance in Geriatric Patients With Hyponatremia.</brief_title>
  <official_title>Phenotypic Characterization of Neuropsychologic and Physical Performance in Geriatric Patients Suffering From Hyponatremia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Volker Burst</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Cologne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our purpose is to investigate the improvement of the cognitive, neuropsychologic and physical&#xD;
      capabilities using a standardized multidimensional geriatric assessment (MGA) consisting of a&#xD;
      battery of validated assays after correction of hyponatremia in patients 70 years or older.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With an occurrence of up to 30%, hyponatremia, defined as a serum sodium concentration of&#xD;
      less than 135 mmol/L, is the most commonly encountered electrolyte disorder in hospitalized&#xD;
      patients today. The highest incidence of hyponatremia is found in the elderly.&#xD;
&#xD;
      Retrospective analyses clearly show an association between hyponatremia and mortality as well&#xD;
      as morbidity and this association is not confined only to severely decreased sodium levels.&#xD;
      Hyponatremia can be an acute and life-threatening condition, which is usually reflected by&#xD;
      severe signs and symptoms, e.g. coma or seizures,but more often it is of chronic nature, and&#xD;
      symptoms may be subtle or even apparently absent due to cerebral adaptation processes. Signs&#xD;
      and symptoms include, among others, nausea, drowsiness, cognitive impairment, memory&#xD;
      deficits, depression, muscle cramps, or gait instability. However, our knowledge of the&#xD;
      highly diverse clinical picture of hyponatremia stems from anecdotic reports and experiments&#xD;
      that were performed by the investigators on themselves in the 1930ies. Thus, no accurate and&#xD;
      thorough description of the symptomatology of hyponatremiain disease has been carried out so&#xD;
      far, except maybe for the extreme conditions, i.e. in patients suffering from seizures or&#xD;
      coma. This is why especially patients with chronic mild-to-moderate hyponatremia (sometimes&#xD;
      defined as a sodium concentration &gt; 125 mmol/L) who may well have subtle or unspecific&#xD;
      symptoms are often perceived as being asymptomatic. Recent investigations have demonstrated&#xD;
      that such patients have a significantly increased risk for falls and bone fractures and&#xD;
      reduced cognitive capacities. Moreover, anecdotic reports have shown that some patients that&#xD;
      were believed to suffer from depression or dementia improved markedly after correction of&#xD;
      their concomitanthyponatremia. There is also mounting evidence that hyponatremia induces&#xD;
      osteoporosis which adds to the risk of bone fractures. Furthermore, in the SALT-trials, the&#xD;
      mental component of the SF-12 questionnaire (Short Form-12) improved significantly after&#xD;
      hyponatremia had been corrected. Interestingly, the mean sodium concentration prior to&#xD;
      treatment was 129 mmol/L indicating mild or moderate hyponatremia. Given the high prevalence&#xD;
      of mild-to-moderate hyponatremiain the elderly, unspecific symptoms like mood instability,&#xD;
      cognitive deficits or others, thatare often attributed to old age could simply be a&#xD;
      consequence of their low sodium level.&#xD;
&#xD;
      To this end, it might well be that by treating hyponatremia the morbidity/mortality in this&#xD;
      population could be reduced and quality of life improved. In light of the growing&#xD;
      medico-economic challenges we are facing secondary to the steadily increasing life expectancy&#xD;
      and the demographic evolution in the western world and the medical problems that come along&#xD;
      with this development the influence of successful correction of hyponatremia on mental and&#xD;
      physical health should be evaluated. To our knowledge this has not been investigated so far.&#xD;
&#xD;
      The syndrome of inappropriate ADH secretion (SIADH) accounts for more than a third of all&#xD;
      cases of hyponatremia and probably is by far the most frequent aetiology of chronic mild to&#xD;
      moderate hyponatremia. While newly developed SIADH is often induced by malignancies,&#xD;
      pulmonary or cerebral disease in the general population, longstanding chronic hyponatremia in&#xD;
      elderly is usually due to idiopathic or drug-associated SIADH. Apart from SIADH, hypovolemia&#xD;
      or reduction of the effective arterial blood volume, e.g. in cardiac failure or liver&#xD;
      cirrhosis, are common causes of hyponatremia. Although hyponatremia might have an impact on&#xD;
      the mental and physical status as well as on the patient's prognosis regardless of the&#xD;
      underlying cause, most aetiologies except for SIADH might be confounding factors, since they&#xD;
      often induce a &quot;hyponatremia-like&quot; clinical picture by themselves, e.g. hepatic&#xD;
      encephalopathy in liver disease etc. Another possible confounder may be hemoglobin. Recent&#xD;
      work shows that hyponatremia is associated with anaemia, which is a highly prevalent symptom&#xD;
      in elderly patients and an acknowledged risk factor for poor outcome in this population. The&#xD;
      underlying pathogenesis of this association is still unknown. Regarding the fact that anaemia&#xD;
      and hyponatremia are both risk factors for increased morbidity and mortality in elderly&#xD;
      patients that are potentially curable, analysis of influence on the multidimensional&#xD;
      geriatric assessment (MGA) before and after correction is challenging. To our knowledge,&#xD;
      these possible confounders have not been accounted for in the existing literature. Moreover,&#xD;
      no accurate evaluation of the origin of hyponatremia has been reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of the impact of serum sodium concentration on geriatric assessment scores.</measure>
    <time_frame>Day of admission - 14 to 21 days</time_frame>
    <description>The impact of serum sodium concentration on geriatric assessment scores will be evaluated individually for each assessment score in a linear model, independent variables being a) increment of serum sodium [mmol/L] from the time of the first MGA at hospital admission to the time of the second MGA prior to discharge, and b) baseline serum sodium [mmol/L] at the time of the first MGA at hospital admission, the dependent variable being change of assessment score. A subgroup analysis will be done for SIADH patients.&#xD;
The association between geriatric assessments and serum sodium [mmol/L] will be analysed by correlation analysis at the time of the first and second MGA.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Influence of anaemia as a confounder.</measure>
    <time_frame>day of admission - 14 to 21 days</time_frame>
    <description>To test for a possible influence of anaemia as a confounder, similar analyses will carried out using haemoglobin [g/dl] as the independent factor and compared to the above mentioned analyses.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Hyponatremia</condition>
  <arm_group>
    <arm_group_label>Not treatment</arm_group_label>
    <description>Patients with the age of 70 years or above, that have a serum sodium of below 130 mmol/L on admission. All patients will be routinely evaluated at admission with a standardized multidimensional geriatric assessment (MGA) consisting of a battery of validated assays.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Multidimensional Geriatric Assessment (MGA)</intervention_name>
    <description>The MGA contains the following tests:&#xD;
Barthel Katz Index (activity of daily living, ADL)&#xD;
Mini Mental State Test (MMST)&#xD;
DemTec (dementia detection test)&#xD;
Clock Test&#xD;
Geriatric Depression Scale (GDS)&#xD;
Tinetti Test&#xD;
TUG (timed up-and-go Test)&#xD;
Esslinger Transfer Scale (ETS)&#xD;
Handgrip Test&#xD;
Mini Nutritional Assessment (MNA)</description>
    <arm_group_label>Not treatment</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 150 patients with the age of 70 years or above, that are admitted to the&#xD;
        Department for Geriatric Medicine of the University of Cologne, that have a serum sodium of&#xD;
        below 130 mmol/L on admission, and that have complete datasets that allow for unequivocal&#xD;
        determination of the etiologic cause of hyponatremia will be enrolled in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age of 70 years or above&#xD;
&#xD;
          -  serum sodium of 130 mmol/L and below&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients not capable of giving informed consent&#xD;
&#xD;
          -  patients on intensive care unit (ICU)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Volker Burst, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department II of Internal Medicine, Nephrology - University Hospital of Cologne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department for Geriatric Medicine - University of Cologne</name>
      <address>
        <city>Cologne</city>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>August 8, 2019</last_update_submitted>
  <last_update_submitted_qc>August 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Cologne</investigator_affiliation>
    <investigator_full_name>Volker Burst</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyponatremia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02242604
org study id: V1.1
secondary id: DRKS00005776
nct id: NCT02242604
lead sponsor: 
has dmc: No
Our purpose is to investigate the improvement of the cognitive, neuropsychologic and physical
      capabilities using a standardized multidimensional geriatric assessment (MGA) consisting of a
      battery of validated assays after correction of hyponatremia in patients 70 years or older.
With an occurrence of up to 30%, hyponatremia, defined as a serum sodium concentration of
      less than 135 mmol/L, is the most commonly encountered electrolyte disorder in hospitalized
      patients today. The highest incidence of hyponatremia is found in the elderly.

      Retrospective analyses clearly show an association between hyponatremia and mortality as well
      as morbidity and this association is not confined only to severely decreased sodium levels.
      Hyponatremia can be an acute and life-threatening condition, which is usually reflected by
      severe signs and symptoms, e.g. coma or seizures,but more often it is of chronic nature, and
      symptoms may be subtle or even apparently absent due to cerebral adaptation processes. Signs
      and symptoms include, among others, nausea, drowsiness, cognitive impairment, memory
      deficits, depression, muscle cramps, or gait instability. However, our knowledge of the
      highly diverse clinical picture of hyponatremia stems from anecdotic reports and experiments
      that were performed by the investigators on themselves in the 1930ies. Thus, no accurate and
      thorough description of the symptomatology of hyponatremiain disease has been carried out so
      far, except maybe for the extreme conditions, i.e. in patients suffering from seizures or
      coma. This is why especially patients with chronic mild-to-moderate hyponatremia (sometimes
      defined as a sodium concentration > 125 mmol/L) who may well have subtle or unspecific
      symptoms are often perceived as being asymptomatic. Recent investigations have demonstrated
      that such patients have a significantly increased risk for falls and bone fractures and
      reduced cognitive capacities. Moreover, anecdotic reports have shown that some patients that
      were believed to suffer from depression or dementia improved markedly after correction of
      their concomitanthyponatremia. There is also mounting evidence that hyponatremia induces
      osteoporosis which adds to the risk of bone fractures. Furthermore, in the SALT-trials, the
      mental component of the SF-12 questionnaire (Short Form-12) improved significantly after
      hyponatremia had been corrected. Interestingly, the mean sodium concentration prior to
      treatment was 129 mmol/L indicating mild or moderate hyponatremia. Given the high prevalence
      of mild-to-moderate hyponatremiain the elderly, unspecific symptoms like mood instability,
      cognitive deficits or others, thatare often attributed to old age could simply be a
      consequence of their low sodium level.

      To this end, it might well be that by treating hyponatremia the morbidity/mortality in this
      population could be reduced and quality of life improved. In light of the growing
      medico-economic challenges we are facing secondary to the steadily increasing life expectancy
      and the demographic evolution in the western world and the medical problems that come along
      with this development the influence of successful correction of hyponatremia on mental and
      physical health should be evaluated. To our knowledge this has not been investigated so far.

      The syndrome of inappropriate ADH secretion (SIADH) accounts for more than a third of all
      cases of hyponatremia and probably is by far the most frequent aetiology of chronic mild to
      moderate hyponatremia. While newly developed SIADH is often induced by malignancies,
      pulmonary or cerebral disease in the general population, longstanding chronic hyponatremia in
      elderly is usually due to idiopathic or drug-associated SIADH. Apart from SIADH, hypovolemia
      or reduction of the effective arterial blood volume, e.g. in cardiac failure or liver
      cirrhosis, are common causes of hyponatremia. Although hyponatremia might have an impact on
      the mental and physical status as well as on the patient's prognosis regardless of the
      underlying cause, most aetiologies except for SIADH might be confounding factors, since they
      often induce a "hyponatremia-like" clinical picture by themselves, e.g. hepatic
      encephalopathy in liver disease etc. Another possible confounder may be hemoglobin. Recent
      work shows that hyponatremia is associated with anaemia, which is a highly prevalent symptom
      in elderly patients and an acknowledged risk factor for poor outcome in this population. The
      underlying pathogenesis of this association is still unknown. Regarding the fact that anaemia
      and hyponatremia are both risk factors for increased morbidity and mortality in elderly
      patients that are potentially curable, analysis of influence on the multidimensional
      geriatric assessment (MGA) before and after correction is challenging. To our knowledge,
      these possible confounders have not been accounted for in the existing literature. Moreover,
      no accurate evaluation of the origin of hyponatremia has been reported.
observational model: Case-Only
time perspective: Prospective
measure: Evaluation of the impact of serum sodium concentration on geriatric assessment scores.
time frame: Day of admission - 14 to 21 days
description: The impact of serum sodium concentration on geriatric assessment scores will be evaluated individually for each assessment score in a linear model, independent variables being a) increment of serum sodium [mmol/L] from the time of the first MGA at hospital admission to the time of the second MGA prior to discharge, and b) baseline serum sodium [mmol/L] at the time of the first MGA at hospital admission, the dependent variable being change of assessment score. A subgroup analysis will be done for SIADH patients.
The association between geriatric assessments and serum sodium [mmol/L] will be analysed by correlation analysis at the time of the first and second MGA.
measure: Influence of anaemia as a confounder.
time frame: day of admission - 14 to 21 days
description: To test for a possible influence of anaemia as a confounder, similar analyses will carried out using haemoglobin [g/dl] as the independent factor and compared to the above mentioned analyses.
arm group label: Not treatment
description: Patients with the age of 70 years or above, that have a serum sodium of below 130 mmol/L on admission. All patients will be routinely evaluated at admission with a standardized multidimensional geriatric assessment (MGA) consisting of a battery of validated assays.
intervention type: Other
intervention name: Multidimensional Geriatric Assessment (MGA)
description: The MGA contains the following tests:
Barthel Katz Index (activity of daily living, ADL)
Mini Mental State Test (MMST)
DemTec (dementia detection test)
Clock Test
Geriatric Depression Scale (GDS)
Tinetti Test
TUG (timed up-and-go Test)
Esslinger Transfer Scale (ETS)
Handgrip Test
Mini Nutritional Assessment (MNA)
arm group label: Not treatment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Volker Burst, MD
role: Principal Investigator
affiliation: Department II of Internal Medicine, Nephrology - University Hospital of Cologne
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: University of Cologne
investigator full name: Volker Burst
investigator title: MD
mesh term: Hyponatremia