Perioperative Aminophylline to Improve High Risk Renal Graft Outcome- a Double Blinded, Placebo Controlled, Randomized Clinical Trial
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
- 否
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
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
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
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
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
Orly Haskin
Pediatric Nephrology
Stanford University
