Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia

Completed

• Conditions: Hyponatremia

• Registration Number: NCT01838759
• Lead Sponsor: Zonguldak Bulent Ecevit University

Brief Summary

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

• Study Start: 2013-02
• Study First Submitted: 2013-04-20
• Study First Submitted QC: 2013-04-20
• Study First Posted: 2013-04-24
• Primary Completion: 2013-08
• Study Completion: 2013-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-30
• Last Update Posted: 2014-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of volume status measured by bioimpedance spectroscopy	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

Name	Time	Method
Laboratory data and echocardiography	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

Trial Locations

Locations (1)

Bulent Ecevit University Hospital; 🇹🇷 Zonguldak, Turkey