Prevention of Akute Kidney Injury With Human Atrial Natriuretic Peptide in Patients Undergoing Heart Transplant.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- GFR 4-5 days after Htx
研究概览
简要总结
Prospective, blinded, placebo-controlled trial. Patients: Adult patients (>18 years of age) undergoing de novo Htx, with a preoperative GFR > 30ml/min, not receiving an ABO-incompatible organ with an ischemia time of > 6 hours. A donor age > 70 years is an exclusion criteria.
Intervention: Infusion of h-ANP fore five days, starting at the induction of anesthesia.
Outcome: Kidney function, evaluated with serum creatinine day 1-7 and kidney clearance, 4-5 Days after Htx plus after 3 and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •De novo Htx.
- •Preoperative GFR > 30ml/min/1,73m
- •>18 years old.
- •Written consent.
排除标准
- •Multi organ transplantation or previous heart transplant.
- •Donor age > 70 years.
- •Dialysis.
- •ABO-incompatible organ.
- •Donor heart ischemia time > 6 tim.
- •Known kidney disease.
- •Other planed study within 2 mounth.
研究组 & 干预措施
ANP
Infusion of h-ANP at dose of 50ng/kg/min fore 5 days, starting at the induction of anesthesia.
干预措施: ANP (Drug)
Placebo
Infusion of NaCl at the same volyme as for ANP for 5 days.
干预措施: Placebo (Drug)
结局指标
主要结局
GFR 4-5 days after Htx
时间窗: 4-5 days
次要结局
- GFR 1 year after Htx(1 year)
研究者
Maria Tholén
MD
Sahlgrenska University Hospital, Sweden