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临床试验/NCT02951299
NCT02951299Unknown2 期

Branch Director, Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital.

Taipei Medical University Hospital0 个研究点目标入组 140 人开始时间: 2017年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
140
主要终点
Renal outcome

研究概览

简要总结

Acute kidney injury (AKI) has a frequency of 7.0 % in hospital inpatients and is especially common in critically ill patients, in whom the prevalence of acute kidney injury is greater than 40% at admission to the intensive care unit if sepsis is present. Therefore, alternative strategies are required to confer better or more complete renoprotection for those who suffered from AKI.

There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We thereby design this controlled, non-randomized clinical trial, aiming at investigating the potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.

详细描述

Acute kidney injury (AKI) refers to a clinical syndrome characterized by a rapid (hours to days) decrease in renal function, which is a common and important diagnostic and therapeutic challenge for clinicians. The disorder has a frequency of 7.0 % in hospital inpatients and is especially common in critically ill patients, in whom the prevalence of acute kidney injury is greater than 40% at admission to the intensive care unit if sepsis is present. AKI is independently associated with important morbidity and mortality although many efforts have been used in past years. Therefore, alternative strategies are required to confer better or more complete renoprotection for those who suffered from AKI.

There had been many studies demonstrated that the phosphodiesterase inhibitor pentoxifylline (PTX) is a potent anti-inflammatory, anti-proliferative, and anti-fibrotic agent capable of attenuating experimental renal disease such as drugs, ischemic and sepsis induced AKI. We thus hypothesized that PTX may have therapeutic value for AKI in human. We thereby design this controlled, non-randomized clinical trial, aiming at investigating the potential renoprotective efficacy of PTX, as compared to placebo, in 200 patients with AKI.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 20 ~ 70 y/o who had admitted for acute kidney injury (renal function decreased within 48hours which meets following criteris: GFR decreased > 25 %, serum creatinine elevated > 0.3 mg/dl or 50%、urine amount less than 0.5 ml/kg/hour > 6 hours).

排除标准

  • Those who had been received regular dialysis or GFR < 30 ml/min before test.
  • Those who with acute bleeding.
  • Those who allergy to pentoxifylline or methylxanthine derivatives (such as caffeine, theophylline and theobromine )..

研究组 & 干预措施

pentoxifylline group

Experimental

Received oral pentoxifylline (400 mg) three times a day for 14 days.

干预措施: Pentoxifylline 400Mg Tablet (Drug)

结局指标

主要结局

Renal outcome

时间窗: 4 weeks

Need of dialysis

次要结局

  • Renal function tests(4 weeks)
  • inflammation marker(4 weeks)

研究者

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

Hsi-Hsien Chen

Medical attending

Taipei Medical University Hospital

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