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NCT00936325 · ClinicalTrials.gov registry record
Studies in the Pathogenesis of Systemic Capillary Leak Syndrome
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 152
- Enrollment target
NCT00936325 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 152 participants.
The verdict
NCT00936325 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 152 participants
- Enrollment target
Study Summary
Background: * Systemic Capillary Leak Syndrome (SCLS) is a disorder of unknown cause characterized by episodes of life-threatening drop in blood pressure and leakage of fluids into tissues. The outcome from an episode of SCLS may be mild and resolve on its own, or may be severe and result in death. Although SCLS likely involves abnormalities in the cells lining blood vessels, the specific cause(s) of this disorder are not known. * The treatment of choice for an acute SCLS episode is intravenous fluids and drugs such as norepinephrine (adrenaline), which are given to keep blood pressure at a level that will maintain vital organ function. This may be followed by a course of intravenous steroids and IVIG. Currently, there is no cure, but IVIG has been effective in diminishing the frequency and/or intensity of SCLS episodes when given regularly, as long-term effective preventive therapy for many patients who experience recurrent episodes of SCLS. * This protocol is focused on understanding what causes SCLS with the hope that research findings will lead to the design of safe and more effective treatments. Objectives: \- To investigate mechanisms that may cause Systemic Capillary Leak Syndrome. Eligibility: * Patients between 16 and older who have been diagnosed with SCLS. Patients who have been diagnosed with SCLS and are between the ages of 7 and 16 may participate off-site, by sending specimens to the NIH. Patients 16 and older who have been diagnosed with SCLS and cannot travel to the NIH may also participate off-site. * Patients must have a documented history of at least one episode of SCLS with all three of the following documented on at least one occasion: low blood volume, low blood pressure without cause, and evidence of protein leakage during the episode. A letter of a referral from a treating physician is also required. Design: * Patients seen on site will be evaluated at the National Institutes of Health (NIH) for approximately 4 to 5 days on an inpatie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2009-08-24 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00936325
The ClinicalTrials.gov registry entry for NCT00936325 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 0 interventions.
NCT00936325 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00936325 about?
NCT00936325 is a clinical study titled "Studies in the Pathogenesis of Systemic Capillary Leak Syndrome". Background: * Systemic Capillary Leak Syndrome (SCLS) is a disorder of unknown cause characterized by episodes of life-threatening drop in blood pressure and leakage of fluids into tissues. The outcome from an episode of SCLS may be mild and resolve on its own, or may be severe and result in death....
What is the current status of trial NCT00936325?
This trial is currently completed. The enrollment target is 152 participants. The study started on 2009-08-24.
Who is sponsoring clinical trial NCT00936325?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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