Characterization of Neuropsychologic and Physical Performance in Geriatric Patients With Hyponatremia.

NCT02242604 | Completed

• 2 other identifiers: V1.1DRKS00005776
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyponatremia

Outcome Measures

Primary Outcomes (1)

• Evaluation of the impact of serum sodium concentration on geriatric assessment scores.

  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.

  Day of admission - 14 to 21 days

Secondary Outcomes (1)

• Influence of anaemia as a confounder.

  day of admission - 14 to 21 days

Study Arms (1)

Not treatment

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.

Other: Multidimensional Geriatric Assessment (MGA)

Interventions

Multidimensional Geriatric Assessment (MGA) OTHER

The MGA contains the following tests: 1. Barthel Katz Index (activity of daily living, ADL) 2. Mini Mental State Test (MMST) 3. DemTec (dementia detection test) 4. Clock Test 5. Geriatric Depression Scale (GDS) 6. Tinetti Test 7. TUG (timed up-and-go Test) 8. Esslinger Transfer Scale (ETS) 9. Handgrip Test 10. Mini Nutritional Assessment (MNA)

Not treatment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A total of 150 patients with the age of 70 years or above, that are admitted to the Department for Geriatric Medicine of the University of Cologne, that have a serum sodium of below 130 mmol/L on admission, and that have complete datasets that allow for unequivocal determination of the etiologic cause of hyponatremia will be enrolled in this study.

You may qualify if:

• age of 70 years or above
• serum sodium of 130 mmol/L and below

You may not qualify if:

• patients not capable of giving informed consent
• patients on intensive care unit (ICU)

Sponsors & Collaborators

• Volker Burst: lead

Study Sites (1)

Department for Geriatric Medicine - University of Cologne

Cologne, 50937, Germany

Location

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Volker Burst, MD

  Department II of Internal Medicine, Nephrology - University Hospital of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 17, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: August 1, 2017
• Last Updated: August 9, 2019

Record last verified: 2019-08

Locations

DE (1)