跳至主要内容
临床试验/CTRI/2019/05/019383
CTRI/2019/05/019383尚未招募不适用

Phosphate kinetics in Indian hemodialysis patients - an observational study

Dr Namrata Rao S1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年5月28日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
To prospectively evaluate phosphate removal by hemodialysis in patients with endstage renal disease in a tertiary care hospital in northern India

研究概览

简要总结

Hyperphosphatemiain endstage renal disease patients has been associated with greater risk ofmortality, especially due to cardiovascular causes (1). Most commonly,nephrologists employ an approach of dietary phosphorus restriction, use ofphosphate binders and hemodialysis, to facilitate maintenance of serumphosphate levels in dialysis patients. A majority of Indian dialysis patientsreceive two/week hemodialysis sessions, as against three/week in the Westernworld. Indian diet is vastly different from typical Western diet and variousregional differences exist too. Dietary modifications to increase protein and minimizephosphorus intake, are only variably successful, as cost and logistics play greaterrole in deciding the patient’s diet, rather than the clinician’s advice (1).Therefore, the onus of phosphate removal falls upon a combination of phosphatebinders and the hemodialysis sessions.

Briefreview: Regardingdialytic phosphorus removal, available literature is unclear whether short,frequent hemodialysis sessions are more beneficial than prolonged sessions inreducing serum phosphorus levels (2,3). To our knowledge, only a single study hasevaluated dialytic phosphorus removal over a period of time (4). This studyfound out that while the first hour of hemodialysis normalizes serum phosphoruslevels, significant amount of phosphorus continues to be removed in thesubsequent hours as well. The present study will observe dialysis phosphorusremoval at hourly intervals and help in deciding which approach will tackle hyperphosphatemia  effectively – increasing dialysis duration orfrequency. Moreover, no other study has undertaken the evaluation of dietaryphosphorus intake and dialytic phosphorus removal in an Indian populationbefore.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • •Patient of endstage renal disease on maintenance hemodialysis for > 3 months No hospitalizations in the last 3 months Written, informed consent.

排除标准

  • •Need for hospitalization in the last 3 months Inability to record diet and drug history Hemodialysis sessions requiring blood transfusion Missed session of hemodialysis in the preceding week.

结局指标

主要结局

To prospectively evaluate phosphate removal by hemodialysis in patients with endstage renal disease in a tertiary care hospital in northern India

时间窗: 0,1,2,3,4,5 hours after onset of dialysis

次要结局

未报告次要终点

研究者

发起方
Dr Namrata Rao S
申办方类型
Government medical college

研究点 (1)

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