- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00029731
Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
Arginine Therapy for Acute Chest Syndrome in Sickle Cell Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pneumonia in patients with SCD can be particularly severe and has come to be called acute chest syndrome. ACS is a common cause of morbidity in SCD patients and is the most common cause of death in SCD. Multiple factors are involved in the severity of acute pulmonary injury in SCD. Nitric oxide has a multitude of related functions, many of which could impact favorably on ACS in SCD. Nitric oxide is an important inflammatory mediator which is produced by the conversion of L-arginine to citrulline by nitric oxide synthase. Nitric oxide and its precursor, arginine, are known to be low in SCD patients with ACS, suggesting that therapies, such as arginine, aimed at increasing nitric oxide production will improve the clinical course of ACS. Patients will receive 1 of 3 doses of arginine hydrochloride orally 3 times a day for 3 days while hospitalized. The efficacy of arginine will be measured by the increase in nitric oxide production and the physiological effects will be assessed.
Completion date provided represents the completion date of the grant per OOPD records
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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Oakland, California, United States, 94609
- Children's Hospital Oakland
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Diagnosis of sickle cell disease (Hb SS, SC, or Sbeta thalassemia)
Acute chest syndrome with the following:
- New pulmonary infiltrate on chest radiography involving a full segment of the lung and 1 of the following:
- Fever
- Cough, tachypnea, retractions, rales, or wheezing
- Chest pain
Exclusion criteria:
- Inability to take or tolerate oral medications
- Hepatic dysfunction (SGPT greater than 2 times normal)
- Renal dysfunction (creatinine greater than 2 times normal)
- Mental status or neurological changes
- Allergy to arginine
- History of priapism
- Pregnancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FD-R-1978-01
- FD-R-001978-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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