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
|
|
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
|
|
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
|
|
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. |