Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia

October 30, 2014 updated by: Ender Hur, Zonguldak Bulent Ecevit University
We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of hyponatremia

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Zonguldak, Turkey, 67300
        • Bulent Ecevit University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to Bulent Ecevit University Hospital with the presentation of hyponatremia

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zonguldak Bulent Ecevit University

Investigators

  • Study Chair: Ender Hur, Assoc.Prof., Bulent Ecevit University Medical School, Division of Nephrology, Zonguldak, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 20, 2013

First Submitted That Met QC Criteria

April 20, 2013

First Posted (Estimate)

April 24, 2013

Study Record Updates

Last Update Posted (Estimate)

November 2, 2014

Last Update Submitted That Met QC Criteria

October 30, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEUN 2013-31-26/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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