Vaso-occlusive Pain Episodes Clinical Trial
Official title:
Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial
Vaso-occlusion contributes significantly to morbidity in sickle cell disease (SCD). Vaso-occlusive painful episodes (VOE) are common and debilitating, causing the majority of emergency department visits. Currently efforts to treat painful episodes with use of non-steroidal pain relievers and intravenous narcotics offer symptomatic relief only, without targeting the underlying mechanisms of vaso-occlusion.Investigators have found that an arginine deficiency and low NO bioavailability occurs during painful events in SCD. Since arginine is the obligate substrate for NO production, and an acute deficiency is associated with VOE, investigators hypothesized that arginine supplementation may be a safe and beneficial treatment for sickle cell pain.
| Status | Completed |
| Enrollment | 56 |
| Est. completion date | June 2007 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Years to 21 Years |
| Eligibility |
Inclusion Criteria: - Established Diagnosis of Sickle Cell Disease(SS,SC,S-beta thal) - Admitted to Hospital for pain - Pain requiring hospitalization for parenteral narcotics, not attributable to non-sickle cell causes - >3 year and older Exclusion Criteria: - Hemoglobin less than 5gm/dL or immediate need for red cell transfusion - Hepatic Dysfunction: increased in SGPT to >2x normal value - Renal Dysfunction: increased in creatinine to >2x normal value or >1.5 - Mental status or neurological changes - Pregnancy - >10 Hospitalizations per year or history of dependance to narcotics - Inability to take oral medications or allergy to arginine - Inability to use a PCA device - < 3 years of age |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Childrens Hospital Research Center Oakland | Oakland | California |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital & Research Center Oakland |
United States,
Morris CR, Kuypers FA, Lavrisha L, Ansari M, Sweeters N, Stewart M, Gildengorin G, Neumayr L, Vichinsky EP. A randomized, placebo-controlled trial of arginine therapy for the treatment of children with sickle cell disease hospitalized with vaso-occlusive — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Length of Hospital Stay | participants will be followed for the duration of hospital stay an expected average of 3-6 days, with re-admission data being collect for up to 30 days | No | |
| Secondary | Effect on Pain Score | participants will be followed for the duration of hospital stay an expected average of 3-6 days | No | |
| Secondary | Total Opioid Use (mg/kg) | participants will be followed for the duration of hospital stay an expected average of 3-6 days | No |