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Study of Idiopathic Edema

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ClinicalTrials.gov Identifier: NCT01681927
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Idiopathic Edema Nocturia

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Idiopathic Edema
Study Start Date : September 2011
Primary Completion Date : November 2016
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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.
>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.
> 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.


Outcome Measures

Primary Outcome Measures :
  1. Orthostatic weight exceeding 1.4 kg/day [ Time Frame: 1 day ]
    the subject will record weights upon arising and before retiring at night.


Secondary Outcome Measures :
  1. Nocturia [ Time Frame: overnight ]
    The subject will record and save all urines excreted after retiring for the night and upon arising in the morning.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with idiopathic edema
Criteria

Inclusion Criteria:

  • Subjects gaining > 1.4 kg and nocturia

Exclusion Criteria:

  • those not gaining > 1.4 kg and without nocturia
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681927


Locations
United States, New York
Winthrop-University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: John K Maesaka, MD Winthrop University Hospital
More Information

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 ( Other Identifier: Winthrop-University Hospital )
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Keywords provided by John Maesaka, MD, Winthrop University Hospital:
idiopathic edema nocturia

Additional relevant MeSH terms:
Edema
Nocturia
Signs and Symptoms
Lower Urinary Tract Symptoms
Urological Manifestations