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临床试验/NCT01796678
NCT01796678已完成2 期

Arginine Therapy in Sickle Cell Disease-VOC Clinical Trial

UCSF Benioff Children's Hospital Oakland1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2000年9月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

100 mg/kg T.I.D 3x a day IV or PO

干预措施: Arginine (Drug)

Placebo

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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