Clinical trial NCT01681927: Study of Idiopathic Edema
Official title: Study of Idiopathic Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Edema Nocturia
Keywords: idiopathic edema nocturia
Lead sponsor: Winthrop University Hospital
Sponsor class: OTHER
First posted: 2012-09-10
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with idiopathic edema

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.

Detailed description: All postmenarchal female patients over the age of 14 years will be eligible to enter the study except for the following exclusions: serum creatinine \> 2.0 mg/dl, patients with diabetes insipidus-nephrogenic and central, those on lithium therapy and diuretics that cannot be held for 3 days. Subjects under the age of 18 will be asked tp complete the questionnaire, which requires that the subject record the weights at 8 AM and 10 PM and whether they get up at night to urines. If they gain more than three pounds during the day and get up at night to urinate, they will be asked to keep a record of their weights and the number of times they get up at night to urinate for one week. A consent form for patients below the age of 18 has been developed for this age-group. Patients will be recruited from referrals from the different subspecialty groups in the Winthrop Hospital system, mainly pediatric endocrinology, obstetric and gynecology, neurology, ophthalmology, cardiology and gastroenterology practices.

The subjects will be placed in the following groups:

Group I: nonedematous patients

1. polycystic ovaries
2. autonomic failure-male and female
3. Age and gender matched normals Group II-Edema not meeting criteria for idiopathic edema

1.Congestive heart failure 2.Cirrhosis of liver 3.Nephrosis 4.Pregnancy 5.Pre eclampsia 6.Unknown cause of edema, such as obesity. Group III-Orthostatic weight gain of \> 3 lbs between 8 AM and 10 PM with nocturia

1. Idiopathic edema, include patients in Group I-fluctuations in weight/nocturia
2. Autonomic failure, include patients in Group I-fluctuations in weight/nocturia

Group III subjects will undergo the following procedures:

1. Record weights in pajamas before bedtime and after excreting first urine upon arising in the morning for 1 week.
2. Record the number of times they get up to urinate and collect all urines passed overnight in separate containers, including urine excreted upon arising in the morning. The patient will record the time and date on each container provided for this purpose.

24 hour study:

1. Blood will be collected after waking up the following morning and at 7 PM the same day. Blood will be analyzed for renal profile, renin, aldosterone, uric acid, phosphorus
2. All urines excreted from the time after arising in the morning and collected in separate containers throughout the following 24 hours and the times of collection noted. The urines will be analyzed for osmolality, sodium, potassium, creatinine, uric acid, urea and phosphorus.

Bioimpedance Studies:

Patients in group III will have bioimpedance studies performed in the morning upon arising and in the evening to determine any change in body composition, i.e. change in volume of extracellular, intracellular and total body water.

Collection of Interstitial Fluid:

In selected patients, an 18g needle will be placed subcutaneously in the mid-thigh and the interstitial fluid collected by gravity to obtain 2-3 ml of fluid for analysis in late afternoon. A blood sample will be obtained after completion of the sampling of edema fluid. The serum will be analyzed for renal profile, total protein, albumin and electrophoresis. The interstitial fluid will analyzed for renal profile, osmolality, total protein, albumin and electrophoresis.

Fluorescein dye studies:

Patients in Group III and selected patients with polycystic ovaries without edema over the age of 18 years will undergo a standard ophthalmologic fluorescein dye test to detect any increase in vascular endothelial permeability. Patients with diabetes mellitus will be excluded from this study.

Eligibility criteria: Inclusion Criteria:

* Subjects gaining \> 1.4 kg and nocturia

Exclusion Criteria:

* those not gaining \> 1.4 kg and without nocturia

Primary outcomes:
measure: Orthostatic weight exceeding 1.4 kg/day
timeFrame: 1 day
Secondary outcomes:
measure: Nocturia
timeFrame: overnight
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop-University Hospital
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: John K Maesaka, MD
role: PRINCIPAL_INVESTIGATOR
References: