To evaluate the effect of an interventional approach vs a conventional approach in incident peritoneal dialysis patients

Recruiting

• Conditions: Peritoneal Dialysis Patients

• Registration Number: CTRI/2013/04/003561
• Lead Sponsor: Baxter Evidence Council

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-03
• Last Update Posted: 2013-01-29

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Stable incident CKD stage 4 patients 2.
• Must be willing to give consent.

Exclusion Criteria

• Patient unwilling/unable to provide consent 2.
• Patient who are anuric or oliguric, at time of enrollment 3.
• Patient with life expectancy of less than 12 months 4.
• Pregnant or Lactating Women 5.
• Patient with history of likehood of poor compliance.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	End of study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Meenakshi Mission Hospital and Research Centre (MMHRC); 🇮🇳 Madurai, TAMIL NADU, India

Meenakshi Mission Hospital and Research Centre (MMHRC)

🇮🇳Madurai, TAMIL NADU, India

Dr Krishnaswamy Sampathkumar

Principal investigator

9994872250

drksampath@gmail.com