Plasma Exchange for Autoimmune Autonomic Failure
Public ClinicalTrials.gov record NCT00359346. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will explore whether an antibody is influencing the autonomic nervous system, and if its removal will eliminate signs and symptoms of failure in that system. The autonomic nervous system is responsible for many automatic changes involved in everyday activities, such as standing up, digesting food, and exercising in the heat. Antibodies fight germs but sometimes cause health problems. Removal of the antibody is done through a procedure called a plasma exchange. Patients with primary chronic autonomic failure and a circulating antibody to what is called the neuronal nicotinic receptor may be eligible for this study. To be eligible, patients will have participated in an earlier study, protocol number 03-N-0004. Patients will undergo tests and procedures that include an electrocardiogram, and blood collection for hepatitis, HIV, and pregnancy. Blood will be tested for a complete blood count, clotting factors, and chemistries. There will also be tests for liver function, kidney function, cortisol, and thyroid. Participants will be tested for signs and symptoms of autonomic failure, and will be asked to complete questionnaires about various symptoms before the plasma exchange, 1 or 2 weeks afterward, and then monthly or bimonthly for up to 1 year. Patients will undergo a series of other tests. In one test, a patient is upright and blows against a resistance (Valsalva maneuver). The quantitative sudomotor axon reflex test (QSART) uses iontophoresis, involving application of acetylcholine, a chemical messenger, and a small amount of electricity. QSART examines the regulation of sweating, a particular aspect of the autonomic nervous system. There will be a test using edrophonium, given intravenously (IV), to evaluate that drug's effects on the heart, skin, glands, gastrointestinal activity, bladder tone, and salivation. A glucagon test, also by IV, will show patients' ability to release the hormone adrenaline. The plasma exchange will be performed by use of an automated cell separator. Patients' blood will be removed continuously through a needle in the arm. Blood cells will be separated from the plasma by a spinning process and continuously returned to circulation through a needle in the patients' opposite arm. Blood cells that are returned will be mixed with albumin, a sterile replacement solution. A blood thinner, citrate, will be given, to prevent clotting of blood. This whole procedure will take about 2 hours. Patients will typically undergo five exchange procedures in about 10 days while they are inpatients at the NIH Clinical Center. The amount of plasma removed in a single session and the number of sessions will be set by the NIH Blood Bank. It is expected that patients' autonomic failure will improve after several days of starting the plasma exchange. Testing for symptoms of autonomic failure and autonomic function testing will occur about 1 month after the plasma exchange and monthly or bimonthly for up to 1 year. For each visit of testing, patients will be inpatients for about 2 days. If autonomic failure recurs, patients may have a second plasma exchange, with the same follow-up tests, for about 1 year.
Study identification
- NCT ID
- NCT00359346
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 3 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 18 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 13, 2006
- Primary completion
- Not listed
- Completion
- Apr 15, 2009
- Last update posted
- Jul 1, 2017
2006 – 2009
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00359346, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 1, 2017 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00359346 live on ClinicalTrials.gov.