随机对照试验，旨在确定在导管插入后启动腹膜透析的适当时间，以最大程度减少并发症（及时 PD 研究）。
Randomised controlled trial to determine the appropriate time to initiate peritoneal dialysis after insertion of catheter to minimise complications (Timely PD study).
机构信息
Renal Medicine, Royal Brisbane and Women's Hospital, Brisbane, Queensland, 4029, Australia.
出版信息
BMC Nephrol. 2010 Jun 22;11:11. doi: 10.1186/1471-2369-11-11.
BACKGROUND
The most appropriate time to initiate dialysis after surgical insertion of Tenckhoff catheters is not clear in the literature. There is the possibility of peritoneal dialysis (PD) complications such as leakage and infection if dialysis is started too soon after insertion. However, much morbidity and expense could be saved by reducing dependency on haemodialysis (HD) by earlier initiation of PD post catheter insertion. Previous studies are observational and mostly compare immediate with delayed use. The primary objective is to determine the safest and shortest time interval between surgical placement of a Tenckhoff catheter and starting PD.
METHODS/DESIGN: This is a randomised controlled trial of patients who will start PD after insertion of Tenckhoff catheter at Royal Brisbane and Women's Hospital (RBWH) or Rockhampton Base Hospital (RBH) who meet the inclusion criteria. Patients will be stratified by site and diabetic status. The patients will be randomised to one of three treatment groups. Group 1 will start PD one week after Tenckhoff catheter insertion, group 2 at two weeks and group 3 at four weeks. Nurses and physicians will be blinded to the randomised allocation. The primary end point is the complication rate (leaks and infection) after initiation of PD.
DISCUSSION
The study will determine the most appropriate time to initiate PD after placement of a Tenckhoff catheter.
TRIAL REGISTRATION
ACTRN12610000076077.
背景
在经手术植入 Tenckhoff 导管后何时开始透析尚不明确。如果在插入后过早开始透析，可能会发生腹膜透析（PD）并发症，如渗漏和感染。然而，通过在导管插入后尽早开始 PD，可减少对血液透析（HD）的依赖，从而节省大量的发病率和费用。既往研究为观察性研究，大多比较即刻与延迟使用。主要目标是确定 Tenckhoff 导管插入后开始 PD 的最安全和最短时间间隔。
方法/设计：这是一项在符合纳入标准的 Royal Brisbane and Women's Hospital（RBWH）或 Rockhampton Base Hospital（RBH）接受 Tenckhoff 导管插入后开始 PD 的患者中进行的随机对照试验。患者将根据地点和糖尿病状况进行分层。患者将随机分为三组治疗组。第 1 组将在 Tenckhoff 导管插入后一周开始 PD，第 2 组在两周时开始，第 3 组在四周时开始。护士和医生将对随机分配情况不知情。主要终点是 PD 开始后的并发症发生率（渗漏和感染）。
讨论
该研究将确定在放置 Tenckhoff 导管后开始 PD 的最佳时间。
试验注册
ACTRN12610000076077。
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