跳至主要内容
临床试验/NCT03474367
NCT03474367Unknown不适用

Cost-effectiveness of Urgent-start Therapies Hemodialysis and Peritoneal Dialysis

Universidade Estadual Paulista Júlio de Mesquita Filho1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
198
试验地点
1
主要终点
Cost effectiveness analysis of unplanned PD and HD at the General Hospital of the School of Medicine of Botucatu (HC-FMB)

研究概览

简要总结

This study will evaluate the cost-effectiveness of unplanned dialysis (peritoneal dialysis and hemodialysis) in chronic kidney disease (CKD) during the first year of therapy in a single center.

详细描述

Despite evidence of worse outcomes, initiation of renal replacement therapy by unplanned modalities in chronic kidney disease (CKD) patients is the reality in the practice for both hemodialysis and peritoneal dialysis. Unplanned therapy peritoneal dialysis (PD) is the initiation of the modality in less than 48 hours after implantation of the peritoneal catheter, without family training or adequacy of the home. Unplanned hemodialysis (HD) is the initiation of the method without a functional arteriovenous fistula, i.e., with a central venous catheter (nontunneled or tunneled).

Growing evidence shows unplanned PD (or urgent start PD) as a viable and safe alternative to unplanned HD, with the similar rates of infection and survival.

On planned scenario, solid studies demonstrate that PD has a better cost-effectiveness when compared to HD, however the literature lacks in this kind of analysis in unplanned methods.

Briefly, the workgroup will follow patients that would anyway start a Renal Replacement Therapy by an unplanned method and register Government payment for the therapy, including the therapy direct costs and the costs with events (internation, infection), access for dialysis, laboratory and CKD specific medications to performed a cost-effectiveness analysis in both groups (Unplanned Hemodialysis and Unplanned Peritoneal Dialysis).

The workgroup is responsible for the placement of the catheters (PD and HD) using the Seldinger Technique.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ambulatorial Chronic Kidney Disease patients stage 5 (eGFR < 15 ml/min) or stages 4 with abrupt worsening requiring dialysis treatment immediately followed or not by nephrologists prior to Renal Replacement Therapy indication.

排除标准

  • Transitions between HD and PD
  • Patients with functional arteriovenous fistula entering hemodialysis
  • Patients with functional PD access implanted ate least 48h before the first use
  • Patient or family trained in PD and/or with the right adequacy of the home

结局指标

主要结局

Cost effectiveness analysis of unplanned PD and HD at the General Hospital of the School of Medicine of Botucatu (HC-FMB)

时间窗: 12 months

Cost effectiveness analysis of unplanned PD and HD with the data collected at our center

次要结局

  • Cost effectiveness analysis of unplanned PD and HD in national and international scenario(12 months)

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Minetto Brabo

Mastering Student

Universidade Estadual Paulista Júlio de Mesquita Filho

研究点 (1)

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