跳至主要内容
临床试验/NCT01759862
NCT01759862已完成不适用

Perioperative Aminophylline to Improve High Risk Renal Graft Outcome- a Double Blinded, Placebo Controlled, Randomized Clinical Trial

Stanford University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Calculated Estimated Glomerular Filtration Rate (eGFR)

研究概览

简要总结

The aim of this study is to evaluate whether peri-transplant administration of a drug named aminophylline to children undergoing a kidney transplant from deceased donors improves early graft function and also projects on long term graft function.

详细描述

This is a Double-blinded, placebo-controlled, randomized, clinical trial to evaluate whether administration of aminophylline starting pretransplant until post-transplant day 5 improves early kidney function and projects also on long term graft function.

Study Arms and intervention: On admit to the hospital prior to transplant, patients will be randomized into treatment or control arms. The randomization will be based on age groups 1-5y, 5-12y and 12-18y Treatment arm: Patients will receive aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.

Control arm: Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20doses.

The only difference between the two arms will be the study intervention. Other than that all patients will receive the same standard of care for patients undergoing a kidney transplant.

Theophylline drug levels will be monitored every morning from all patients for the first 4 days post- transplant. Theophylline levels will be reported independently by the laboratory in a faxed research report directly to the pharmacist who will perform dose adjustments, according to the following table.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
1 Year 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Pediatric kidney transplant recipients less than 21 years of age
  • Patients undergoing deceased donor (DD) kidney transplants

排除标准

  • Known history of non-sinus tachycardia
  • Multiple organ transplants recipients
  • Severe liver dysfunction
  • graft was placed on pump after harvesting

研究组 & 干预措施

Aminophylline

Experimental

Patients will receive aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.

Theophylline drug levels will be monitored daily for 4 days.

干预措施: Aminophylline (Drug)

Aminophylline

Experimental

Patients will receive aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.

Theophylline drug levels will be monitored daily for 4 days.

干预措施: Theophylline drug levels (Other)

Control

Placebo Comparator

Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20 doses.

Drug levels will be monitored daily for 4 days.

干预措施: Theophylline drug levels (Other)

Control

Placebo Comparator

Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20 doses.

Drug levels will be monitored daily for 4 days.

干预措施: Placebo (Drug)

结局指标

主要结局

Calculated Estimated Glomerular Filtration Rate (eGFR)

时间窗: 5 days

The investigators will measure blood creatinine on post-operative day 5 and using the Schwartz equation will calculate estimated glomerular filtration rate (GFR) to determine kidney function.

次要结局

  • Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)/ Creatinine Ratio(12 hours post transplant)

研究者

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

Orly Haskin

Pediatric Nephrology

Stanford University

研究点 (1)

Loading locations...

相似试验