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Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients - NCT00029731-94609(Clinical Trial 114058)



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City:  Oakland
State:  
CA
Zip Code: 94609
Conditions: Anemia, Sickle Cell - Pneumonia
Purpose: This is a study to determine if oral arginine will increase nitric oxide in sickle cell disease (SCD) patients with acute chest syndrome (ACS). It will also assess the effects of arginine in the body and how the body uses nitric oxide in ACS.
Study summary: 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.
Criteria: 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 is available at: Children's Hospital Oakland
Oakland, CA 94609
United States

Primary Contact:
Lori A. Styles, M.D.
Email: lstyles@mail.cho.org
Phone: 510-428-3553
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 21, 2011
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