- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01425125
Fractional Urate Excretion in Nonedematous Hyponatremia
Study of Nonedematous Hyponatremia and the Utility of Fractional Urate Excretion in Hyponatremia and Suspected Renal Salt Wasting Without Hyponatremia-
Study Overview
Status
Intervention / Treatment
Detailed Description
The investigators have demonstrated that a normal FEurate in a nonedematous hyponatremic patient is highly consistent with the diagnosis of reset osmostat (RO). Since as much as 36% of patients with SIADH have RO, the investigators will evaluate these patients by either noting dilute urines in spontaneously excreted urines or after a modified water-loading test. The investigators have found that a normal FEurate in a nonedematous hyponatremic patient is highly consistent with RO.
The investigators intend to treat euvolemic patients with hyponatremia with tolvaptan, the V2 ADH receptor blocker, to determine the effectiveness of this form of therapy in a group of patients in whom correction of hyponatremia has been difficult to achieve by usual methods.
Nonedematous hyponatremic patients with serum sodium < 135 mmol/l will be recruited from Winthrop-University Hospital and from our outpatient practice.
It is anticipated that the present studies will provide valuable information on the relative prevalence of SIADH and C/RSW in patients with nonedematous hyponatremia. One possible drawback to these studies is our inability to determine total and extracellular water volumes in patient who are admitted to the neuro/neurosurgical ICU where the acute illnesses require parenteral therapy that will create a nonsteady state situation where total and extracellular water volumes cannot be accurately determined. This is an important possible omission because volume studies in this population of studies have indicated more that two thirds of patients having decreased volumes that were consistent with C/RSW, yet the medical literature states that C/RSW is rare. Studies in hyponatremics elsewhere in the hospital should shed important light on the methods to differentiate SIADH from C/RSW, data which can assist us in differentiating both syndromes in the neuro/neurosurgical ICU, where the investigators intend to perform FEurates.
It is anticipated that volume studies in patients with Alzheimer's disease with normal serum sodium and increased FEurate will demonstrated decreased volumes and confirm our earlier observations that many of these patients are renal salt wasters. It would be interesting to test whether volume repletion with saline will improve them mentally and physically.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Mineola, New York, United States, 11501
- Winthrop-University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nonedematous hyponatremia with normal renal, adrenal and thyroid function. -Non-hyponatremia with increased fractional excretion of urate.
Exclusion Criteria:
- Subjects < 18 years of age
- Pregnancy
- Serum creatinine > 1.4 mg/dl
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tolvaptan in euvolemic hyponatremia
This arm will test the effectiveness of tolvaptan in treating the hyponatremia of patients with euvolemic hyponatremia.
|
This arm will test the effectiveness of tolvaptan in treating the hyponatremia of patients with euvolemic hyponatremia.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Etiologic categorization of nonedematous hyponatremia
Time Frame: 2 years
|
We will attempt to categorize the etiology of nonedematous hyponatremia by the following parameters in decreasing order of importance, total and extracellular water determinations, fractional urate excretion, plasma renin and aldosterone levels, urinary sodium concentration and urine osmolality.
We will also determine total and extracellular water in a group suspected of having renal salt wasting by virtue of having increased fractional urate excretion and normal serum sodium concentrations.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: John K Maesaka, MD, Winthrop University Hospital
- Study Director: Louis J Imbriano, MD, Winthrop University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Nutrition Disorders
- Body Weight
- Body Weight Changes
- Water-Electrolyte Imbalance
- Emaciation
- Weight Loss
- Hyponatremia
- Wasting Syndrome
- Cachexia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Antidiuretic Hormone Receptor Antagonists
- Tolvaptan
Other Study ID Numbers
- 10029 (Other Identifier: Winthrop University Hospital IRB)
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.
Clinical Trials on SIADH
-
Otsuka Frankfurt Research Institute GmbHUnknownSIADH | Non-SIADH Hyponatremia | Non-HyponatremiaDenmark, Germany, Italy, Norway, Spain, Sweden, United Kingdom
-
King's College Hospital NHS TrustRecruiting
-
Zealand University HospitalUnknown
-
Hadassah Medical OrganizationUnknownHyponatremia | SIADHIsrael
-
Hospital San Carlos, MadridCompletedHyponatremia | Hypovolemia | SIADHSpain
-
Polderman, Kees, H., MD, PhDUniversity of PittsburghTerminated
-
Universitair Ziekenhuis BrusselRecruitingFrailty | Asymptomatic Bacteriuria | Geriatric Syndrome | SIADHBelgium
-
University Hospital, Basel, SwitzerlandCompleted
-
Otsuka Pharmaceutical Europe LtdCompletedHyponatremia | Syndrome of Inappropriate ADH (SIADH) SecretionSpain
-
Otsuka Pharmaceutical Europe LtdCompletedHyponatremia | Syndrome of Inappropriate ADH (SIADH) SecretionGermany, Spain