ACTRN12617000358347已完成3 期
An investigator-initiated, pragmatic, registry-based, multi-centre, double-blind, randomised controlled trial evaluating the effect of Plasmalyte versus 0.9% saline on early kidney transplant function in deceased donor kidney transplantation.
Australasian Kidney Trials Network (University of Qld)0 个研究点目标入组 808 人开始时间: 2017年3月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 808
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- All
入选标准
- •1.Adult or child with ESKD, of any cause, on maintenance dialysis, or who has chronic kidney disease with an estimated glomerular filtration rate of <15 mL/min/1.73m2 (as determined by the CKD-EPI equation for adults or the bedside Schwartz equation for children)
- •2.Planned deceased donor kidney transplant from a brain-death (DBD) or circulatory-death (DCD) organ donor expected to occur within the next 24 hours
- •3.Written informed consent, or consent given by their parent or guardian (if age <18), or other authorised person.
排除标准
- •1.Planned live donor kidney transplant (except where this is cancelled in favour of transplantation from a deceased donor)
- •2.Planned multi-organ transplant (dual or en-bloc kidney transplants are not excluded)
- •3.Be a child with a weight <20 kg, or a child that the treating physician believes should not be included in a study of blinded fluids due to their small body size
- •4.Known hypersensitivity to the trial fluid preparations or packaging.
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