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临床试验/NCT05414669
NCT05414669已完成4 期

The Effect of Allopurinol on Malondialdehyde, Nitric Oxide, Kidney Injury Molecule-1 Urine Levels, Resistive Index and Renal Elastography in Kidney Stone Patients After Extra Corporeal Shockwave Lithotripsy

Sanglah General Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2020年8月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
Oxidative Stress

研究概览

简要总结

Extracorporeal shock wave lithotripsy (ESWL) is accepted as the first treatment choice for most urinary stones. Still, it has adverse effects on the kidneys. The mechanism underlying the shock wave induced renal injury is not entirely understood, and oxidative stress has been speculated to be involved in this process. The Investigator evaluated the role of allopurinol, which works as a xanthine oxidase inhibitor and free radical scavenger in renal protection against oxidative effects of ESWL. In a randomized, double-blind placebo-controlled trial, a total of 70 patients with renal stones undergoing ESWL were randomly assigned to 2 groups. Group 1 receive allopurinol, and group 2 receive a placebo. Allopurinol 300mg was given orally for a total of 3 days, beginning a day before ESWL. The urinary excretion of malondialdehyde (MDA), nitric oxide (NO), and kidney injury molecule-1 (KIM-1) were determined by quantitative double antibody sandwich direct ELISA at baseline before ESWL then repeatedly two h, and 24 h after ESWL. The resistive index (RI) change of the interlobar artery was asses along with the measurement of the shear wave velocity (SWV) in the focal zone of the treated kidney before, two weeks, and four weeks after ESWL. Multivariate analyses were performed using repeated measure ANOVA to control covariates.

详细描述

Subjects with kidney stones who met the criteria were given a detailed explanation about this study by the research team, then followed by signing the informed consent. History was taken along with physical examination, complete blood count, Bun, creatinine, uric acid, urinalysis and also anthropometric measurements (weight and height). Then each subjects got one of the intervention drugs, either allopurinol 300mg or placebo. Allopurinol 300 mg was finely grounded and put into gelatin capsules. The placebo was made by using Saccharum lactis material which was inserted into a gelatin capsule as well. The shape, color, texture, and weight of the placebo capsules were made the same as the drug allopurinol. Allopurinol capsules and placebo were made by the Pharmacy section of Sanglah Hospital.

Subjects were randomly allocated using a permuted block method into the allopurinol or placebo group. Each subject received one type of capsule consisting of 3 capsules containing 300 mg allopurinol or placebo taken the day before ESWL, 2 hours before ESWL, and the day after ESWL.

The study was conducted double-blind where the researcher, subject, data collector, outcome adjudicator, and data analyst did not know the type of treatment. Medicines are given in sealed envelopes using an undisclosed code that will be uncovered at the end of the study.

For the preparation of ESWL subjects; each subjects got infusion of 0.9% NaCl with 20 drops per minute, ondansetron 8 mg i.v., pethidine bolus 50 mg i.v., followed by drip pethidine 50 mg and ketorolac 30 mg given in 500 ml NaCl 0.9% with 20 drops of 20 drops per minute.

The Investigator performed ESWL using a Siemen litostar vario which uses an electromagnetic generator. The number of shock waves given is 2500-3000 shock waves per session. The given shock wave strength is slim to 2 J in the initial 200 shock wave followed by 3 to 3.5 J in the remainder of the shock wave. The given shock wave frequency is 60 x/minute.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The Key envelope was kept by third party and will be opened once the data analysis is done.

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with renal stone who meet ESWL criteria
  • Age 18 to 59 years old
  • Consent to join this study

排除标准

  • Patient with Diabetes Melitus
  • Patient with hypertension
  • Patient with Chronic Kidney Disease stage IV and stage V
  • Patient with urinary tract infection
  • Patient with obesity
  • Patient with uric acid more than 9mg/dL

研究组 & 干预措施

Interventional group

Experimental

Allopurinol 300 mg was administered orally for a total of 3 days, starting from the day before ESWL

干预措施: Allopurinol Tablet 300 mg (Drug)

Control Group

Placebo Comparator

Placebo was administered orally for a total of 3 days, starting from the day before ESWL

干预措施: Control Group (Drug)

结局指标

主要结局

Oxidative Stress

时间窗: 24 hours post ESWL

Level of Malondialdehyde (MDA), Nitric Oxide (NO), and Kidney Injury molecule-1 (KIM-1) in urine were determined by quantitative double antibody sandwich direct ELISA

Renal vascular and biophysical damage

时间窗: One month after ESWL

Resistive Index (RI) change of the interlobar artery and elastography of the ipsilateral renal focal zone at ESWL

次要结局

未报告次要终点

研究者

发起方
Sanglah General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kadek Budi Santosa

Urologist

Sanglah General Hospital

研究点 (1)

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