Idiopathic Edema NocturiaNCT01681927
Study of Idiopathic Edema
An observational study of Idiopathic Edema Nocturia, run by Winthrop University Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Edema Nocturia
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with idiopathic edema
Who may be able to join
- Subjects gaining > 1.4 kg and nocturia
Who cannot join
- those not gaining > 1.4 kg and without nocturia
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop-University Hospital
Mineola, New York, 11501
About this study
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.
Read the 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
- polycystic ovaries
- autonomic failure-male and female
- 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
- Idiopathic edema, include patients in Group I-fluctuations in weight/nocturia
- Autonomic failure, include patients in Group I-fluctuations in weight/nocturia
Group III subjects will undergo the following procedures:
- Record weights in pajamas before bedtime and after excreting first urine upon arising in the morning for 1 week.
- 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:
- 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
- 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
- Idiopathic Edema Nocturia
- Keywords
- idiopathic edema nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Orthostatic weight exceeding 1.4 kg/day
the subject will record weights upon arising and before retiring at night.
Measured: 1 day
Secondary outcomes (1)
Nocturia
The subject will record and save all urines excreted after retiring for the night and upon arising in the morning.
Measured: overnight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Edema NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Maesaka, MD, Winthrop University Hospital
- Investigators
- John K Maesaka, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681927
- Sponsor's protocol ID
- 220488-4
- Other IDs
- WUH 350-595
- Status last verified
- Nov 2016
- First submitted
- 8 Aug 2012
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Idiopathic Edema
- ClinicalTrials.gov ID
- NCT01681927
- Acronym / sponsor ID
- 220488-4
- Conditions
- Idiopathic Edema Nocturia
- Keywords
- idiopathic edema nocturia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- polycystic ovaries
- autonomic failure-male and female
- 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
- Idiopathic edema, include patients in Group I-fluctuations in weight/nocturia
- Autonomic failure, include patients in Group I-fluctuations in weight/nocturia
Group III subjects will undergo the following procedures:
- Record weights in pajamas before bedtime and after excreting first urine upon arising in the morning for 1 week.
- 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:
- 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
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with idiopathic edema
Key inclusion criteria (1 listed)
- Subjects gaining > 1.4 kg and nocturia
Key exclusion criteria (1 listed)
- those not gaining > 1.4 kg and without nocturia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Orthostatic weight exceeding 1.4 kg/day
Time frame: 1 day
the subject will record weights upon arising and before retiring at night.
1 secondary outcome
Nocturia
Time frame: overnight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John K Maesaka, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Edema Nocturia, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Orthostatic weight exceeding 1.4 kg/day (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.