Safety and Efficacy of Sodium Nitrite in Sickle Cell Disease
Summary
This study will determine if administration of sodium nitrite is safe and can improve small vessel blood flow and tissue oxygenation when given as an additional treatment in patients with acute vaso-occlusive crisis (pain crisis) associated with sickle cell disease.
Description
Nitric oxide (NO) is a naturally occuring chemical that relaxes blood vessels and helps improve blood flow.
The pain associated with vaso-occlusive crisis (pain crisis) in sickle cell disease is caused in part by lack of oxygen and increased tissue acid because blood flow is blocked by stiff sickle red cells. Administration of sodium nitrite should generate nitric oxide in this area of hypoxia and acidosis and improve blood flow.
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Sickle Cell Disease
Intervention
sodium nitrite injection, usp
Location
Childrens Hospital Los Angeles
Los Angeles
California
United States
90027
Status
Recruiting
Source
Children's Hospital Los Angeles
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01033227
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Hemoglobin Sc Disease
One of the sickle cell disorders characterized by the presence of both hemoglobin S and hemoglobin C. It is similar to, but less severe than sickle cell anemia.
Hemoglobin, Sickle
An abnormal hemoglobin resulting from the substitution of valine for glutamic acid at position 6 of the beta chain of the globin moiety. The heterozygous state results in sickle cell trait, the homozygous in sickle cell anemia.
Meningitis, Pneumococcal
An acute purulent infection of the meninges and subarachnoid space caused by Streptococcus pneumoniae, most prevalent in children and adults over the age of 60. This illness may be associated with OTITIS MEDIA; MASTOIDITIS; SINUSITIS; RESPIRATORY TRACT INFECTIONS; sickle cell disease (ANEMIA, SICKLE CELL); skull fractures; and other disorders. Clinical manifestations include FEVER; HEADACHE; neck stiffness; and somnolence followed by SEIZURES; focal neurologic deficits (notably DEAFNESS); and COMA. (From Miller et al., Merritt's Textbook of Neurology, 9th ed, p111)
Sodium Nitrite
Nitrous acid sodium salt. Used in many industrial processes, in meat curing, coloring, and preserving, and as a reagent in ANALYTICAL CHEMISTRY TECHNIQUES. It is used therapeutically as an antidote in cyanide poisoning. The compound is toxic and mutagenic and will react in vivo with secondary or tertiary amines thereby producing highly carcinogenic nitrosamines.
Sodium Channel Blockers
A class of drugs that act by inhibition of sodium influx through cell membranes. Blockade of sodium channels slows the rate and amplitude of initial rapid depolarization, reduces cell excitability, and reduces conduction velocity.
Clinical Trials
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PubMed Articles
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Abstract Preoperative exchange transfusion is a routine practice in patients with sickle cell disease having elevated sickle cell hemoglobin levels (>40%) undergoing open-heart surgery on cardiopulmon...
Neonatal Screening of Sickle Cell Anemia: A Preliminary Report.
OBJECTIVE: To evaluate feasibility of systematic neonatal screening for sickle cell disease in Chhattisgarh. METHODS:...
Increase in gastric pH reduces hypotensive effect of oral sodium nitrite in rats.
The new pathway nitrate-nitrite-nitric oxide (NO) has emerged as a physiological alternative to the classical enzymatic pathway for NO formation from l-arginine. Nitrate is converted to nitrite by com...
