IDEAL Study:透析早期導入に疑問符

Stage V慢性腎疾患の透析早期プラン化導入は生存・臨床的アウトカムを有意に改善せず

GFR 5-7ml/min/1.73 m2に達するまでに透析導入

長期透析の増加が世界でも問題となっており、開始時期は尿毒症の兆候・症状の存在により開始することが世界的には一般的となっている。確かに、観察コホートや症例対照治験で、透析早期導入にて患者の生存率、QoL、労働能力、コンプライアンスなど改善したと報告がある。しかし、この研究の多くは、lead timeによるバイアス、患者選択、参照期間などのバイアスがあるが、析開始時期目標早期化が臨床ガイドラインに用いられている。


A Randomized, Controlled Trial of Early versus Late Initiation of Dialysis
Bruce A. Cooper, M.B., B.S., Ph.D., Pauline Branley, B.Med., Ph.D., Liliana Bulfone, B.Pharm., M.B.A., John F. Collins, M.B., Ch.B., Jonathan C. Craig, M.B., Ch.B., Ph.D., Margaret B. Fraenkel, B.M., B.S., Ph.D., Anthony Harris, M.A., M.Sc., David W. Johnson, M.B., B.S., Ph.D., Joan Kesselhut, Jing Jing Li, B.Pharm., B.Com., Grant Luxton, M.B., B.S., Andrew Pilmore, B.Sc., David J. Tiller, M.B., B.S., David C. Harris, M.B., B.S., M.D., Carol A. Pollock, M.B., B.S., Ph.D., for the IDEAL Study

Published at June 27, 2010 (10.1056/NEJMoa1000552)

Kaplan–Meier Curves for Time to the Initiation of Dialysis and for Time to Death.

Early commencement of dialysis in the patients randomised to the late start group

If a patient has been randomised to commence dialysis late but the treating nephrologist feels that the patient should commence dialysis prior to reaching a GFR of 5-7ml/min/1.73m2 then he/she should do so. Data collection should be performed as outlined in the section entitled Ongoing assessment. An Adverse Event form (Form X) should be completed, the reason for the early commencement of dialysis specified and the patient's RRF at this point in time recorded. Should this occur, the patient would remain in the trial, as the analysis will be performed on the basis of intention to treat.

Late commencement of dialysis in the early start group
If randomised to early start, but the access is insufficiently mature to commence dialysis by 10ml/min/1.73m2. The patient remains in the early start group on an intention to treat basis and an adverse event is recorded

Discontinuation of the trial Patients may withdraw from the trial at any stage if they wish. Alternatively patients may be withdrawn from the trial if their nephrologist feels it is in their best interests. Future trial end point data should be collected where possible.


by internalmedicine | 2010-06-28 10:39 | 医療一般  

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