NCT01838759

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

6 months

First QC Date

April 20, 2013

Last Update Submit

October 30, 2014

Conditions

Keywords

Bioimpedance spectroscopyHypervolemiaHypovolemia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Laboratory data and echocardiography

    6 Months

Study Arms (2)

Hypovolemic hyponatremia

Negative values of "Overhydration" measured by Bioimpedance spectroscopy

Hypervolemic hyponatremia

Positive values of "Overhydration" measured by Bioimpedance spectroscopy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bulent Ecevit University Hospital

Zonguldak, 67300, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 23415416BACKGROUND
  • Kose SB, Hur E, Magden K, Yildiz G, Colak D, Kucuk E, Toka B, Kucuk H, Yildirim I, Kokturk F, Duman S. Bioimpedance spectroscopy for the differential diagnosis of hyponatremia. Ren Fail. 2015 Jul;37(6):947-50. doi: 10.3109/0886022X.2015.1040418. Epub 2015 Apr 27.

MeSH Terms

Conditions

HyponatremiaEdemaHypovolemia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Ender Hur, Assoc.Prof.

    Bulent Ecevit University Medical School, Division of Nephrology, Zonguldak, Turkey

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Doctor

Study Record Dates

First Submitted

April 20, 2013

First Posted

April 24, 2013

Study Start

February 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations