Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia

Hyponatremia Clinical Trial

Official title:

Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01838759
• Other study ID #: BEUN 2013-31-26/02
• Status: Completed
• Phase: N/A
• First received: April 20, 2013
• Last updated: October 30, 2014
• Start date: February 2013
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Zonguldak Karaelmas University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyponatremia

Locations

Country	Name	City	State
Turkey	Bulent Ecevit University Hospital	Zonguldak

Sponsors (1)

Lead Sponsor	Collaborator
Zonguldak Karaelmas University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Hur E, Usta M, Toz H, Asci G, Wabel P, Kahvecioglu S, Kayikcioglu M, Demirci MS, Ozkahya M, Duman S, Ok E. Effect of fluid management guided by bioimpedance spectroscopy on cardiovascular parameters in hemodialysis patients: a randomized controlled trial. Am J Kidney Dis. 2013 Jun;61(6):957-65. doi: 10.1053/j.ajkd.2012.12.017. Epub 2013 Feb 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of volume status measured by bioimpedance spectroscopy	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	No
Secondary	Laboratory data and echocardiography	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; Diuretics; 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	No