Study of Idiopathic Edema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Winthrop University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
John Maesaka, MD, Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01681927
First received: August 8, 2012
Last updated: September 5, 2012
Last verified: September 2012
  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
Idiopathic Edema Nocturia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Idiopathic Edema

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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.

  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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681927

Contacts
Contact: John K Maesaka, MD 516-663-2169 jmaesaka@winthrop.org
Contact: Louis J Imbriano, MD 516-663-2169 limbriano@winthrop.org

Locations
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         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
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:
Edema
Nocturia
Signs and Symptoms
Lower Urinary Tract Symptoms
Urological Manifestations

ClinicalTrials.gov processed this record on September 30, 2014