Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial 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? In addition to clinical testing, functional magnetic resonance imaging (fMRI) will be performed before and after therapy in up to 40 patients with hyponatremia. Functional magnetic resonance imaging (fMRI) is an imaging procedure in which local changes in cerebral oxygen concentration can be used to draw conclusions about brain activity. In connection with the current research project, an initial contribution is to be made in order to close the existing knowledge gap as to whether a functionally-image-morphologically tangible change in cerebral activity can also be depicted non-invasively by means of fMRI during hyponatremia or after its compensation. Another component of cerebral evaluation in this context is volumetry in fMRI. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01879774
Study type Interventional
Source University of Cologne
Contact
Status Completed
Phase N/A
Start date June 2012
Completion date April 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Recruiting NCT04561531 - Efficacy and Safety of Bolus Comparing With Continuous Drip of 3% NaCl in Patients With Severe Symptomatic Hyponatremia. N/A
Terminated NCT02012959 - Study of the Safety and Effectiveness of SAMSCA® (Tolvaptan) in Children and Adolescents With Euvolemic or Hypervolemic Hyponatremia Phase 3
Recruiting NCT02936167 - Comparison of Ringer Lactate and Isotonic Acetate Solution as Perioperative Maintenance Fluid for Children N/A
Completed NCT00621348 - Maintenance Intravenous Fluids in Children Phase 3
Terminated NCT03703713 - Colloid Osmotic Pressure and Osmolality in Hyponatremia
Completed NCT02926989 - Intravenous Fluids in Hospitalised Children Phase 4
Terminated NCT02959411 - Tolvaptan for Advanced or Refractory Heart Failure Phase 4
Completed NCT02573077 - An Observational Study Measuring Outcomes in Cancer Patients Treated for Moderate to Severe Hyponatremia in Italy
Withdrawn NCT02667977 - Reexamining Hypotonic Intravenous Fluid Use N/A
Terminated NCT01708811 - Hyponatremia and Myometrium Contractility. An Invitro Study N/A
Withdrawn NCT01326429 - Frequency and Origin of Dysnatremias in the Emergency Department N/A
Completed NCT01456533 - Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients N/A
Terminated NCT01227512 - Effects of Tolvaptan vs Fluid Restriction in Hospitalized Subjects With Dilutional Hyponatremia Phase 3
Recruiting NCT06013800 - Hyponatremia Volume Status Analysis by Point-of-care Ultrasound
Terminated NCT04020926 - Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function
Completed NCT02545101 - An Observational Study on Real-world Use and Outcomes of Patients Treated With Tolvaptan for Hyponatraemia Due to SIADH N/A
Withdrawn NCT02442674 - A Trial of Tolvaptan in Children and Adolescent Subjects With Euvolemic and Hypervolemic Hyponatremia Phase 3
Terminated NCT02215148 - Pharmacokinetics and Clinical Response of Tolvaptan in Neurocritical Care Patients N/A
Recruiting NCT01748331 - The Effect of Fluid Restriction in Congestive Heart Failure Complicated With Hyponatremia N/A