Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Length of Hospital Stay
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 3 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arginine
100 mg/kg T.I.D 3x a day IV or PO
干预措施: Arginine (Drug)
Placebo
Saline or sugar pill
干预措施: Placebo (Drug)
结局指标
主要结局
Length of Hospital Stay
时间窗: 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
次要结局
- Effect on Pain Score(participants will be followed for the duration of hospital stay an expected average of 3-6 days)
- Total Opioid Use (mg/kg)(participants will be followed for the duration of hospital stay an expected average of 3-6 days)
