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Home > "A" Clinical Trials Conditions > Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients  Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
For Condition: Anemia, Sickle Cell,Pneumonia
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Uncontrolled, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 5 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 30
Location and Contact Information:
Children's Hospital Oakland *Recruiting*
Oakland, California, 94609
United States
Recruiting Lori Styles 510-428-3553
Additional Information:
Study ID Numbers: FD-R-1978-01; FD-R-001978-01
Study Start Date: August 2001
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029731
Other Pneumonia Studies:
1. Stem Cell Transplantation after Reduced-Dose Chemotherapy for Patients with Sickle Cell Disease or Thalassemia
2. Pediatric Hydroxyurea in Sickle Cell Anemia (BABY HUG)
3. Induction of Stable Chimerism for Sickle Cell Anemia
4. Pediatrics:Chlamydia, Sickle Cell Anemia and Stroke Risk - Ancillary to STOP II
5. Investigation of Selected Patient Groups From The Cooperative Study of Sickle Cell Disease
Related Studies:
Other Pneumonia Clinical Trials
Other California Clinical Trials
Other Oakland Clinical Trials
Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients
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