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临床试验/NCT02455960
NCT02455960Unknown4 期

Protective Effects of Oral L-Arginine Supplement in Patients With CKD After Intravenous Contrast Media Injection

Phramongkutklao College of Medicine and Hospital2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
112
试验地点
2
主要终点
Incidence of Contrast-induced acute kidney injury (CI-AKI)

研究概览

简要总结

This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in chronic kidney disease (CKD) patients.

详细描述

Contrast-induced acute kidney injury (CI-AKI) is a common complication in hospitalized patients. Nitric oxide-signal transduction plays an important role in prevention of CI-AKI. L-Arginine is an amino acid involved in ammonia detoxification, and is well known as a precursor to nitric oxide, a key component of endothelial-derived relaxing factor.

This is a prospective randomized, double blind, placebo controlled trial among CKD stage 3-4 patients undergoing computer tomography. Eligible patients were randomly assigned to two groups: (1) arginine 3 g/day or 6 capsules per day, and (2) placebo 6 capsules per day for 3 days before contrast media injection. Serum cystatin C, serum creatinine and estimated GFR was measured at baseline and 48 hours after procedure.

研究设计

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

入排标准

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

入选标准

  • Age ≥ 18 years
  • Stable CKD stage 3-4 patients
  • Patients undergoing elective contrast media injection

排除标准

  • History of arginine allergy
  • Acute kidney injury diagnosed within 4 weeks
  • Active infection/sepsis
  • Severe liver disease

结局指标

主要结局

Incidence of Contrast-induced acute kidney injury (CI-AKI)

时间窗: 48 hours

次要结局

  • Number of Adverse effects(48 hours)

研究者

发起方
Phramongkutklao College of Medicine and Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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