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Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Cologne
Sponsor:
Information provided by (Responsible Party):
Volker Burst, University of Cologne
ClinicalTrials.gov Identifier:
NCT01879774
First received: April 23, 2013
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

The aim of this epidemiological study is to characterize the neuropsychological and motoric performance in patients with hyponatremia. Newer studies revealed an association between mild hyponatremia and unstable walking, frequency of falls and risk of a fracture, questioning the paradigm of an "asymptomatic" hyponatremia. 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.


Condition Intervention
Hyponatremia
Other: Neuropsychological and motoric tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia

Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Assessment of Performance in individual tests [ Time Frame: Change in individual tests at Baseline and at the earliest 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Neuropsychological and motoric tests
Neuropsychological and motoric tests are conducted.
Other: Neuropsychological and motoric tests

Evaluation before and after therapy of hyponatremia

  1. Neuropsychological tests

    • Mini Mental Status Test
    • Dem-Tect
    • Rey-Osterrieth Complex Figure Test
    • Trailmaking Test
    • Beck Depression Inventory
    • d2-R (optional)
  2. Motoric tests

    • modified UPDRS (Unified Parkinson Disease Rating Scale) Part III
    • Timed-up-and-go Test
    • Halstead Fingertapping Test
    • AIMS (Abnormal involuntary movement scale)
  3. EEG

Detailed Description:

Hyponatremia is the most common electrolyte disorder in outpatients and hospitalized patients. The prevalence of hospital-associated hyponatremia is estimated to be up to 40%. Especially mild to moderate hyponatremia (125-136 mmo/l) without apparent symptoms has seldomly been accurately assessed but rather seen as clinically irrelevant. Cognitive limitations, unstable gait and motoric disorders as well as depressive conditions were described in smaller studies and single case reports.

In terms of the question, if a therapeutic influence is also reasonable in slight symptomatic hyponatremia it is necessary to establish an accurate phenotyping of patients with hyponatremia, which quantifies the individual cognitive, motoric and psychological qualities.

Patients with hyponatremia will be examined on the basis of standardized neuropsychological and neurological tests. Following questions are to be answered with this study:

  1. Which cognitive, motoric and psychological functions are impaired due to hyponatremia?
  2. Is there a correlation between the extend of hyponatremia and the different test results?
  3. Is there an intraindividual difference in test results during hyponatremia and normal sodium concentrations?
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • traumatic cerebral injury, hemorrhagic and ischemic insult as cause of hyponatremia
  • professional or private relationship between subject and the investigators, or dependance on the investigators
  • Placement in an institution based on official orders
  • Patients who are unable to give informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879774

Contacts
Contact: Volker Burst, MD +49 221 478 86285 volker.burst@uk-koeln.de
Contact: Torsten Kubacki, MD torsten.kubacki@uk-koeln.de

Locations
Germany
University of Cologne Recruiting
Cologne, Germany, 50937
Principal Investigator: Volker Burst, MD         
Sub-Investigator: Torsten Kubacki, MD         
Sub-Investigator: Marco Witthus, MD         
Sub-Investigator: Franziska Grundmann, MD         
Sponsors and Collaborators
University of Cologne
Investigators
Principal Investigator: Volker Burst, MD University Hospital of Cologne
  More Information

No publications provided

Responsible Party: Volker Burst, Principal Investigator, University of Cologne
ClinicalTrials.gov Identifier: NCT01879774     History of Changes
Other Study ID Numbers: 002
Study First Received: April 23, 2013
Last Updated: June 11, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Cologne:
Hyponatremia

Additional relevant MeSH terms:
Hyponatremia
Metabolic Diseases
Water-Electrolyte Imbalance

ClinicalTrials.gov processed this record on November 25, 2014