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Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia

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ClinicalTrials.gov Identifier: NCT01838759
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : November 3, 2014
Sponsor:
Information provided by (Responsible Party):
Ender Hur, Zonguldak Karaelmas University

Brief Summary:
We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of hyponatremia

Condition or disease
Hyponatremia

Detailed Description:
  • Up to now, "Hyponatremia" differentially diagnosed by physical examination, plasma and urine osmolalities, Echocardiography and biochemical measurements.
  • The purpose of this study is to determine whether bioimpedance spectroscopy can be used for the detection of hypovolemia and hypervolemia for the differential diagnosis of hyponatremia.

Study Type : Observational [Patient Registry]
Actual Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia
Study Start Date : February 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : September 2013

Group/Cohort
Hypovolemic hyponatremia
Negative values of "Overhydration" measured by Bioimpedance spectroscopy
Hypervolemic hyponatremia
Positive values of "Overhydration" measured by Bioimpedance spectroscopy



Primary Outcome Measures :
  1. Accuracy of volume status measured by bioimpedance spectroscopy [ Time Frame: Six months ]

    BIOIMPEDANCE SPECTROSCOPY:

    Overhydration (OH) measurement by Body Composition Monitor (Fresenius Medical Care)

    Negative values of "OH" indicating Hypovolemia and positive values for hypervolemia in hyponatremic patients.



Secondary Outcome Measures :
  1. Laboratory data and echocardiography [ Time Frame: 6 Months ]

    LABORATORY MEASUREMENTS Hemoglobin, Hematocrit, White blood cell count Platelet count, Na, Potassium, Chlorur, Urea, Creatinine, Uric acid, Plasma osmolality, Urine osmolality, Alanine transaminase , Aspartate transaminase , Urine specific gravity,

    TREATMENT MODALITY

    1. Diuretics
    2. Intravenous hydration by isotonic saline

    ECHOCARDIOGRAPHY:

    Left ventricular end-diastolic diameter, Left ventricular end-systolic diameter, Ejection fraction(%), Left Atrium diameter, Aortic diameter, Right atrium diameter, Interventricular septum, Posterior wall thickness, Mitral insufficiency, Pulmonary insufficiency, Systolic pulmonary artery pressure, Tricuspid insufficiency




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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to Bulent Ecevit University Hospital with the presentation of hyponatremia
Criteria

Inclusion Criteria:

  • Willing to participate in the study with written informed consent
  • Older than 18-years

Exclusion Criteria:

  • The presence of pacemaker or defibrillator
  • Artificial joints, pin or amputation
  • Pregnancy or lactating.

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): NCT01838759


Locations
Turkey
Bulent Ecevit University Hospital
Zonguldak, Turkey, 67300
Sponsors and Collaborators
Zonguldak Karaelmas University
Investigators
Study Chair: Ender Hur, Assoc.Prof. Bulent Ecevit University Medical School, Division of Nephrology, Zonguldak, Turkey

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ender Hur, Associate Professor Doctor, Zonguldak Karaelmas University
ClinicalTrials.gov Identifier: NCT01838759     History of Changes
Other Study ID Numbers: BEUN 2013-31-26/02
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: November 3, 2014
Last Verified: October 2014

Keywords provided by Ender Hur, Zonguldak Karaelmas University:
Bioimpedance spectroscopy
Hypervolemia
Hypovolemia

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases