HyponatremiaNCT01838759
Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia
An observational study of Hyponatremia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial summary
We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of hyponatremia Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyponatremia
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Sep 2013
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to Bulent Ecevit University Hospital with the presentation of hyponatremia
Who may be able to join
- Willing to participate in the study with written informed consent
- Older than 18-years
Who cannot join
- The presence of pacemaker or defibrillator
- Artificial joints, pin or amputation
- Pregnancy or lactating.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bulent Ecevit University Hospital
Zonguldak, 67300
About this study
We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of hyponatremia
Read the 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.
- Conditions
- Hyponatremia
- Keywords
- Bioimpedance spectroscopy, Hypervolemia, Hypovolemia
- Medical subject headings
- Hyponatremia, Edema, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypovolemic hyponatremia | Negative values of "Overhydration" measured by Bioimpedance spectroscopy | |
| Hypervolemic hyponatremia | Positive values of "Overhydration" measured by Bioimpedance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (1)
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
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ender Hur, Zonguldak Bulent Ecevit University
- Investigators
- Ender Hur, Assoc.Prof., Study chair, Bulent Ecevit University Medical School, Division of Nephrology, Zonguldak, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838759
- Sponsor's protocol ID
- BEUN 2013-31-26/02
- Status last verified
- Oct 2014
- First submitted
- 20 Apr 2013
- Last updated
- 3 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23415416Kose 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.
PubMed 25915455
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia
- ClinicalTrials.gov ID
- NCT01838759
- Acronym / sponsor ID
- BEUN 2013-31-26/02
- Conditions
- Hyponatremia
- Keywords
- Bioimpedance spectroscopy, Hypervolemia, Hypovolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypovolemic hyponatremia | – | –Negative values of "Overhydration" measured by Bioimpedance spectroscopy |
| Hypervolemic hyponatremia | – | –Positive values of "Overhydration" measured by Bioimpedance spectroscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Bulent Ecevit University Hospital with the presentation of hyponatremia
Key inclusion criteria (2 listed)
- Willing to participate in the study with written informed consent
- Older than 18-years
Key exclusion criteria (3 listed)
- The presence of pacemaker or defibrillator
- Artificial joints, pin or amputation
- Pregnancy or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Laboratory data and echocardiography
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2014.
- Background: PubMed 23415416Hur 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.
- Derived from this study: PubMed 25915455Kose 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ender Hur, Assoc.Prof. study chair
Bulent Ecevit University Medical School, Division of Nephrology, Zonguldak, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of volume status measured by bioimpedance spectroscopy (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01838759, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2014.