Study of Idiopathic Edema
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Purpose
Idiopathic edema (IE) is an ill-defined syndrome of uncertain etiology that occurs virtually exclusively in women. It has also been referred to as cyclical edema, periodic edema, fluid retention syndrome and orthostatic edema.
The present studies were designed to 1. Improve our ability to identify patients with idiopathic edema by extending the clinical criteria from an increase in weight of > 1.4 kg between 8 AM to 10 PM to the inclusion of nocturia, a very important component to the history. Additional aims are to: 2. Demonstrate orthostatic weight gain with or without edema in idiopathic edema and autonomic failure that will identify a greater number of patients suffering from variable degrees of weight gain and compare to controls or other conditions associated with edema. The study will focus mainly on subjects with polycystic ovaries and autonomic failure. 3. Provide a reasonable course of therapy that is presently not well defined. 4. Provide evidence that orthostatic edema or weight gain has two common etiologies, a. an increase in vascular membrane as in idiopathic edema and b. pooling of blood in the lower extremities in autonomic failure due to a lack of vascular tone.
| Condition |
|---|
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Idiopathic Edema Nocturia |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Study of Idiopathic Edema |
- Orthostatic weight exceeding 1.4 kg/day [ Time Frame: 1 day ] [ Designated as safety issue: No ]the subject will record weights upon arising and before retiring at night.
- Nocturia [ Time Frame: overnight ] [ Designated as safety issue: No ]The subject will record and save all urines excreted after retiring for the night and upon arising in the morning.
| Estimated Enrollment: | 75 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1.4kg wt gain 8AM -10 PM
Complete a questionnaire. Measure and record weight in AM and PM.Record for one week,number of times urinated after bedtime and before waking up.
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>1.4kg wt gain 8AM - 10PM no nocturia.
Complete a questionnaire. Measure and record weight in AM and PM.Record for one week,number of times urinated after bedtime and before waking up.
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> 1.4 kg wt gain 8AM -10PM with nocturia
Complete a questionnaire. Measure and record weight in AM and PM. Record the number of times and collect all urine passed overnight in separate containers for one week.Collection of blood and interstitial fluid samples, fluorescein dye angiography, and bioimpedance study.
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Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
patients with idiopathic edema
Inclusion Criteria:
- Subjects gaining > 1.4 kg and nocturia
Exclusion Criteria:
- those not gaining > 1.4 kg and without nocturia
Contacts and Locations| Contact: John K Maesaka, MD | 516-663-2169 | jmaesaka@winthrop.org |
| Contact: Louis J Imbriano, MD | 516-663-2169 | limbriano@winthrop.org |
| United States, New York | |
| Winthrop-University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: John K Maesaka, MD 516-663-2169 jmaesaka@winthrop.org | |
| Contact: Louis J Imbriano, MD 516-663-2169 limbriano@winthrop.org | |
| Principal Investigator: John K Maesaka, MD | |
| Principal Investigator: | John K Maesaka, MD | Winthrop University Hospital |
More Information
No publications provided
| Responsible Party: | John Maesaka, MD, Acting Chief of Nephrology and Hypertension, Winthrop University Hospital |
| ClinicalTrials.gov Identifier: | NCT01681927 History of Changes |
| Other Study ID Numbers: | 220488-4, WUH 350-595 |
| Study First Received: | August 8, 2012 |
| Last Updated: | September 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Winthrop University Hospital:
|
idiopathic edema nocturia |
Additional relevant MeSH terms:
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Edema Nocturia Signs and Symptoms Urological Manifestations |
ClinicalTrials.gov processed this record on May 19, 2013