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临床试验/NCT00718289
NCT00718289已完成4 期

Citrate- Versus Acetate-Based Dialysate in Bicarbonate Haemodialysis: Consequences on Haemodynamics, Coagulation, Acid-Base Status and Electrolytes

Ospedale Regionale di Locarno2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2007年3月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Consequences on systemic haemodynamics

研究概览

简要总结

Background:

A concentrate for bicarbonate haemodialysis acidified with citrate instead of acetate has been marketed in the recent years. The small amount of citrate used (one-fifth of the concentration adopted in regional anticoagulation) protects against intradialyser clotting, minimally affecting the calcium concentration. The aim of this study is to compare the impact of a citrate- and acetate-based dialysate on systemic haemodynamics, coagulation, acid-base status, calcium balance and dialysis efficiency.

Methods:

In 25 patients, 375 dialysis sessions, we will compare acetate (A) with citrate dialysate with (C+) or without (C) calcium supplementation (0.25mmol/L) in a randomized single blind cross-over study. Systemic haemodynamics will be evaluated using pulse wave analysis systems. Coagulation, acid-base status, calcium balance and dialysis efficiency will be assessed using standard biochemical markers.

详细描述

Introduction:

A concentrate for bicarbonate haemodialysis acidified with citric instead of the less physiologic acetic acid has been successfully implemented in the United States in the past 7 years [1-3]. Contrarily to traditional regional citrate anticoagulation, the small amount of citrate used in the acid concentrate (0.8 mmol/L only; about one-fifth of the concentration necessary to achieve anticoagulation [1,4,5]) affects the calcium concentration and the locally enhanced coagulation activation in a limited way, resulting in approximately 10% reduction in post-dialysis ionized calcium and in no measurable systemic anticoagulation [1]. The absence of significant systemic repercussions is related to both, the low amount of citrate used but also the rapid conversion of citrate into bicarbonate taking place in the liver and muscles and determining a higher post-dialysis bicarbonataemia [1,6,7]. Despite the rapid citrate clearance, the local consequences of removing calcium from the blood clotting cascade has measurable positive effects on the dialyser life-span in the "reuse" modality and on the dialysis quality quantified by urea Kt/V [1,3]. The improvement in urea clearance was correlated to a postulated favourable effect on dialyser fibre permeability mediated by the intra-dialyser anticoagulants properties of citrate [1,3,8]. Considering the importance of limiting the biocompatibility related coagulation activation taking place in the extracorporeal circuit [9-17], disposing of a simple way to inhibit it without affecting the systemic coagulation and the bleeding risk [18] is very promising.

Even if thousands of patients have been treated in the recent years with haemodialysis fluids based on citric instead of acetic acid, the haemodynamic tolerance (the reduction in ionized calcium concentration and the increase in bicarbonateamia could both result in a lower intra-dialytic blood pressure [19-25]) and the amount of systemic coagulation activation related to each one of the modalities, were not investigated.

The aim of this randomized, controlled, single blind, cross-over study in single-use dialyser bicarbonate haemodialysis, is to detail the consequences on systemic haemodynamics, coagulation activation, acid-base status, calcium balance and dialysis efficiency of using citric instead of acetic acid in the haemodialysis fluids.

Methods and patients:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

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

  • chronic haemodialysis patients
  • dialysed 3 to 4 hours three times a week, who were
  • clinically stable and without intercurrent illnesses

排除标准

  • intercurrent illnesses

结局指标

主要结局

Consequences on systemic haemodynamics

时间窗: Study duration

次要结局

  • Consequences on coagulation, acid-base status, calcium balance and dialysis efficiency(Study duration)

研究者

发起方
Ospedale Regionale di Locarno
申办方类型
Other

研究点 (2)

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