FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2013/04/003561 [Registered on: 17/04/2013] Trial Registered Retrospectively
Last Modified On: 29/01/2013
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Investigator Initiated Trial]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the effect of an interventional approach vs a conventional approach in incident peritoneal dialysis patients 
Scientific Title of Study   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  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Baxter Clinical Evidence Council   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishnaswamy Sampathkumar 
Designation  Consultant Nephrologist  
Affiliation  Meenakshi Mission Hospital and Research Centre (MMHRC) 
Address  Department of Nephrology Meenakshi Mission Hospital and Research Centre (MMHRC) Lake Area, Melur Road
36, Radhakrishnan Street, Bibkulam, Madurai, Tamil Nadu - 625002
Madurai
TAMIL NADU
625107
India 
Phone  9994872250  
Fax  04522588700  
Email  drksampath@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishnaswamy Sampathkumar 
Designation  Consultant Nephrologist  
Affiliation  Meenakshi Mission Hospital and Research Centre (MMHRC) 
Address  Department of Nephrology Meenakshi Mission Hospital and Research Centre (MMHRC) Lake Area, Melur Road
36, Radhakrishnan Street, Bibkulam, Madurai, Tamil Nadu - 625002
Madurai
TAMIL NADU
625107
India 
Phone  9994872250  
Fax  04522588700  
Email  drksampath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mrs Nagalakshmi AnandaPadmanabhan  
Designation  Chief Executive Officer  
Affiliation  Consortium Clinical Research Pvt. Ltd.  
Address  Consortium Clinical Research Pvt. Ltd., No: 9/41, Sri Kalki Gardens Kuniyamuthur P.O.

Coimbatore
TAMIL NADU
641008
India 
Phone  9789777777  
Fax  04222622224  
Email  naga@consortiumcr.com  
 
Source of Monetary or Material Support  
Baxter Evidence Council  
 
Primary Sponsor  
Name  Baxter Evidence Council  
Address  One Baxter Parkway Deerfield, IL 60015-4625 United States Phone: 800-422-9837 (800-4Baxter) Fax: 800-568-5020  
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishnaswamy Sampathkumar  Meenakshi Mission Hospital and Research Centre (MMHRC)   Department of Nephrology, Meenakshi Mission Hospital and Research Centre (MMHRC) Lake Area, Melur Road 625107 India
Madurai
TAMIL NADU 
9994872250
04522588700
drksampath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Peritoneal Dialysis Patients ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bioimpedance Analyser   Interventional Arm: In this arm fluid balance is maintaind based on the ECW values. Here the ECW (IG) is measured at every followup and the prescriptions will be modified to help patients achieve the ECW (pd) 
Comparator Agent  Conventional Arm  In this arm the fluid balance is maintained based on clinical observation relating to signs and symptoms of fluid overload which essentially dictate prescription modifications.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Stable incident CKD stage 4 patients
2. Must be willing to give consent 
 
ExclusionCriteria 
Details  1. 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. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
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  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2013 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   International Society of Peritoneal Dialysis Journal  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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. Blood work at baseline and at follow-up. Lipid profile will be done at baseline and 6 months.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.

 
 
Close