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NCT01681927 · ClinicalTrials.gov registry record
Study of Idiopathic Edema
A clinical trial, sponsored by Winthrop University Hospital.
- Completed
- Registry status
- 4
- Enrollment target
NCT01681927: Completed study, sponsored by Winthrop University Hospital.
NCT01681927 is a clinical trial that has completed, run by Winthrop University Hospital. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01681927 has completed, sponsored by Winthrop University Hospital.
- COMPLETED
- Registry status
- 4 participants
- Enrollment target
Study 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.
Primary Outcome
the subject will record weights upon arising and before retiring at night.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-11 |
What the finished NCT01681927 record still lists
NCT01681927 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01681927 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01681927 about?
NCT01681927 is a clinical study titled "Study of Idiopathic Edema". 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 ...
What is the current status of trial NCT01681927?
This trial is currently completed. The enrollment target is 4 participants. The study started on 2011-09. Estimated completion is 2016-11.
Who is sponsoring clinical trial NCT01681927?
This trial is sponsored by Winthrop University Hospital, which has 32 total clinical trials registered on ClinicalTrials.gov.
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