MedDataX Logo

Study of Idiopathic Edema

NCT ID: NCT01681927

Last Updated: 2016-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Edema Nocturia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

idiopathic edema nocturia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

>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.

No interventions assigned to this group

> 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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Subjects gaining \> 1.4 kg and nocturia

Exclusion Criteria

* those not gaining \> 1.4 kg and without nocturia
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Winthrop University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John Maesaka, MD

Acting Chief of Nephrology and Hypertension

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John K Maesaka, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Winthrop-University Hospital

Mineola, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WUH 350-595

Identifier Type: OTHER

Identifier Source: secondary_id

220488-4

Identifier Type: -

Identifier Source: org_study_id