Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia
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.
|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|
- 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 ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Neuropsychological and motoric tests
Neuropsychological and motoric tests are conducted.
Other: Neuropsychological and motoric tests
Evaluation before and after therapy of hyponatremia
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:
- Which cognitive, motoric and psychological functions are impaired due to hyponatremia?
- Is there a correlation between the extend of hyponatremia and the different test results?
- Is there an intraindividual difference in test results during hyponatremia and normal sodium concentrations?
Please refer to this study by its ClinicalTrials.gov identifier: NCT01879774
|Contact: Volker Burst, MD||+49 221 478 email@example.com|
|Contact: Torsten Kubacki, MDfirstname.lastname@example.org|
|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|
|Dipartimento di Scienze Biomediche, Sperimentali e Cliniche Mario Serio||Recruiting|
|Firenze, Italy, 50139|
|Contact: Alessandro Peri, Associate Professor|
|Principal Investigator: Alessandro Peri, Associate Professor|
|Hospital Universitario Clinico San Carlos||Recruiting|
|Madrid, Spain, 28040|
|Contact: Isabelle Runkle de la Vega, MD|
|Principal Investigator: Isabelle Runkle de la Vega, MD|
|Principal Investigator:||Volker Burst, MD||University Hospital of Cologne|