Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function

NCT04020926 | Terminated

• 1 other identifier: 2019-00650
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

In this study patients with hyponatremia, defined as a serum sodium \< 126 mmol/L on admission to the hospital will be tested for muscular power by use of a hand grip dynamometer, for cognitive function by use of the Montreal-Cognitive-Assessment and gait stability by use of the Tinetti test. The tests will be performed on admission as well es after correction of hyponatremia.

Conditions

Hyponatremia

Keywords

hyponatremia

Outcome Measures

Primary Outcomes (3)

• Muscle strength

  A.) Change in muscle strength in kilogram before and after correction of hyponatremia.

  Correction of hyponatremia (up to 1 week).

• Mobility assessment

  B.) Change in results for the Tinetti performance-oriented mobility assessment (POMA) to evaluate static and dynamic balance abilities during and after correction of hyponatremia.

  Correction of hyponatremia (up to 1 week).

• Cognitive Function

  C.) Change in results for the Montreal Cognitive Assessment (MOCA) test to assess mild cognitive impairment before and after correction of hyponatremia.

  Correction of hyponatremia (up to 1 week).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will include all consecutive patients \>/= 18 years with a serum sodium level \< 126 mmol/L on admission to the Hospital who give consent.

You may qualify if:

• age 18 years or above
• serum sodium ≤ 125 mmol/L
• informed consent.

You may not qualify if:

• age \< 18 years
• not give or are not able to give informed consent
• K+\<3.5 mmol/l
• K+\>5.0 mmol/l)

Sponsors & Collaborators

• Bürgerspital Solothurn: lead

Study Sites (1)

Buergerspital Solothurn

Solothurn, Canton of Solothurn, 4500, Switzerland

Location

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

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

Study Officials

• Gregor Lindner, M.D.

  Dept. of Internal and Emergency Medicine, Buergerspital Solothurn, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Dept. of Internal and Emergency Medicine

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 16, 2019
• Study Start: October 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)