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临床试验/NCT02007889
NCT02007889Unknown3 期

The Effect of L-carnitine on the Prevention of Renal Scarring in Children With Acute Pyelonephritis

Shahid Beheshti University1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
78
试验地点
1
主要终点
Development of renal scar by doing DMSA renal scan

研究概览

简要总结

Risk factors for parenchymal damage in urinary tract infection are vesicoureteral reflux (VUR),obstructive uropathy,the number of flares of acute pyelonephritis(APN) and delay in treatment of acute infection.The pathogenesis of APN is related to bacterial virulenece,immune response,tissue factors,apoptosis and production of free radicals that lead to fibrosis and renal scarring. Oxidative stress in renal cells may be a critical factor in the pathogenesis of pyelonephritis whereas pharmacological management of the oxidative stress response may provide a therapeutic effect in preventing renal pathologies. Animal model show that L-carnitine alleviated oxidative stress, and acute renal inflammatory injury can be prevented much more effectively by carnitine in addition to conventional antibiotic treatment in pyelonephritis.This study is a simple randomized clinical trial (RCT) evaluating the effect of L-carnitine in addition to antibiotic on preventing renal scaring after acute pyelonephritis in children. Simple non- blind randomized clinical trial on 78 patients in 2 groups (intervention & control) is conducted.Children aged 1 month to 10 years with positive urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute pyelonephritis were enrolled into a clinical trial. Patients were excluded if they had neurogenic bladder, systemic hypertension, obstructive uropathy. Patients in Intervention group are administered 50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens and patients in control group received antibiotic regimens. Primary outcome is the development of renal scar by doing DMSA renal scan on the 7th day of admission and six months after the intervention and compared between groups and secondary outcome is the incidence and severity of pyelonephritis and response to treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
1 Month 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 1 month to 10 years with positive urine culture, clinical findings, and 99mTc-dimercaptosuccinic acid (DMSA) scintigraphy-based evidence in favor of acute pyelonephritis

排除标准

  • neurogenic bladder,
  • systemic hypertension,
  • obstructive uropathy

研究组 & 干预措施

L-carnitine

Active Comparator

50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens

干预措施: L-carnitine (Drug)

结局指标

主要结局

Development of renal scar by doing DMSA renal scan

时间窗: Seven and six months after the intervention

次要结局

  • Severity of pyelonephritis and response to treatment.(Six month after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Azadeh Eshraghi

Clinical Pharmacist

Shahid Beheshti University

研究点 (1)

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