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Arginine Treatment of Acute Chest Syndrome (Pneumonia) in Sickle Cell Disease Patients

Arginine Therapy for Acute Chest Syndrome in Sickle Cell Disease

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00029731
Enrollment
30
Registered
2002-01-22
Start date
2001-08-31
Completion date
2005-07-31
Last updated
2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Sickle Cell, Pneumonia

Keywords

Nitric Oxide, Administration, Oral

Brief summary

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.

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

Interventions

Sponsors

UCSF Benioff Children's Hospital Oakland
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026