Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ender Hur, Zonguldak Karaelmas University
ClinicalTrials.gov Identifier:
NCT01838759
First received: April 20, 2013
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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


Condition
Hyponatremia

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia

Further study details as provided by Zonguldak Karaelmas University:

Primary Outcome Measures:
  • Accuracy of volume status measured by bioimpedance spectroscopy [ Time Frame: Six months ] [ Designated as safety issue: No ]

    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:
  • Laboratory data and echocardiography [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

    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



Enrollment: 58
Study Start Date: February 2013
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hypovolemic hyponatremia
Negative values of "Overhydration" measured by Bioimpedance spectroscopy
Hypervolemic hyponatremia
Positive values of "Overhydration" measured by Bioimpedance spectroscopy

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
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
Study First Received: April 20, 2013
Last Updated: October 30, 2014
Health Authority: Turkey: Ethics Committee

Keywords provided by Zonguldak Karaelmas University:
Bioimpedance spectroscopy
Hypervolemia
Hypovolemia

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

ClinicalTrials.gov processed this record on November 23, 2014