Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Hyponatremia on Muscle Strength, Gait and Cognitive Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04020926
Recruitment Status : Terminated (Study was stopped due to COVID-19 pandemic.)
First Posted : July 16, 2019
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
LINDNER Gregor, Bürgerspital Solothurn

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.

Condition or disease
Hyponatremia

Show Show detailed description

Layout table for study information
Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Hyponatremia on Muscle Strength, Gait and Balance, and Cognitive Function: a Prospective Observational Study
Actual Study Start Date : October 1, 2019
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020



Primary Outcome Measures :
  1. Muscle strength [ Time Frame: Correction of hyponatremia (up to 1 week). ]
    A.) Change in muscle strength in kilogram before and after correction of hyponatremia.

  2. Mobility assessment [ Time Frame: Correction of hyponatremia (up to 1 week). ]
    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.

  3. Cognitive Function [ Time Frame: Correction of hyponatremia (up to 1 week). ]
    C.) Change in results for the Montreal Cognitive Assessment (MOCA) test to assess mild cognitive impairment before and after correction of hyponatremia.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04020926


Locations
Layout table for location information
Switzerland
Buergerspital Solothurn
Solothurn, SO, Switzerland, 4500
Sponsors and Collaborators
Bürgerspital Solothurn
Investigators
Layout table for investigator information
Principal Investigator: Gregor Lindner, M.D. Dept. of Internal and Emergency Medicine, Buergerspital Solothurn, Switzerland
  Study Documents (Full-Text)

Documents provided by LINDNER Gregor, Bürgerspital Solothurn:
Study Protocol  [PDF] May 14, 2019

Layout table for additonal information
Responsible Party: LINDNER Gregor, Director Dept. of Internal and Emergency Medicine, Bürgerspital Solothurn
ClinicalTrials.gov Identifier: NCT04020926    
Other Study ID Numbers: 2019-00650
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LINDNER Gregor, Bürgerspital Solothurn:
hyponatremia
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases