跳至主要内容
临床试验/CTRI/2013/04/003561
CTRI/2013/04/003561招募中不适用

A randomised prospective open label comparative study: To evaluate the effect of an interventional approach (aimed at maintaining near pre dialytic ECW) vs a conventional approach (towards volume control) in incident peritonial dialysis patients on rate of decline of RRF and its association with the cardiovascular outcomes

Baxter Evidence Council1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2013年1月3日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Prospective Analysis of the rate of decline of RRF between two groups of incident ESRD patients on PD; one the interventional group and the other conventional group

研究概览

简要总结

It is a randomized prospective open label comparative study.  The proposed study is based on the fact that pre dialysis patients in stage 4 usually do not require dialysis unless necessitated by any indication for emergency dialysis. In the absence of any fixed and absolute method to calculate dry weight in PD patients, we hypothesize that if the hycirations status of incident dialysis patients on PD is maintained at or near pre dialysis stage; there would be good control of fluid status without compromising on RRF. To this effect, we propose to conduct a pilot study to test this hypothesis.The screening and enrollment shall be done over a period of two years.  All patients conforming to the inclusion and exclusion criteria and give consent shall be enrolled. Enrolled patients shall undergo 1:1 randomization at the time of initiation of peritoneal dialysis where every alternate patient would enter the interventional group.  Both groups of patients will be thoroughly educated at the time of enrollment to recognize signs of fluid overload and dehydration and will be informed to come for hospital visit in case of such an event happening.The patients will also be given patient diaries to maintain a record at home and the data collected will relate to signs and symptoms of fluid imbalance including the body weight and BP.MFBIA would be used to measure ECW. RRF shall be measured at baseline and at every two months interval as a 24 hrs mean of renal clearance of urine & Creatinine.  Blood pressure will be taken during the bimonthly visits of subjects to the centre. Bloodwork at baseline and at follow-up. Lipid profile will be done at baseline and 6months.Evaluation of PET as per the ISPD guidelines 2005 will be done. Quantitative variables and qualitative variables will be compared by students t test and chi square tests. A p value < 0.05 is taken as significant.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Stable incident CKD stage 4 patients
  • Must be willing to give consent.

排除标准

  • Patient unwilling/unable to provide consent
  • Patient who are anuric or oliguric, at time of enrollment
  • Patient with life expectancy of less than 12 months
  • Pregnant or Lactating Women
  • Patient with history of likehood of poor compliance.

结局指标

主要结局

Prospective Analysis of the rate of decline of RRF between two groups of incident ESRD patients on PD; one the interventional group and the other conventional group

时间窗: End of study

次要结局

  • Time to having of urine output in both groups Mean number of anti hypertensive medications in each grouopat the pre defined assessment interval Mean blood pressure in the two groups Change in CV profile of patints from baseline in each group as deduced by 2DEcho Outcomesintwogroups;definedascardiovasculareventsresultinginsymptoms/admissionofpatienttohospitalordeathThenumberofepisodesofdehydrationbetweengroupsNumberofemergencyhospitalizationsintwogroups(End of Study)

研究者

发起方
Baxter Evidence Council
申办方类型
Research institution

研究点 (1)

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