| CTRI Number |
CTRI/2022/01/039108 [Registered on: 04/01/2022] Trial Registered Prospectively |
| Last Modified On: |
30/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Rising the temperature and reducing the flow rate of fluid meant for exchange of waste products from blood in hemo ( blood ) dialysis and its impact on removal of waste products in end stage kidney disease patients - a strategy for conservation of water |
|
Scientific Title of Study
|
Increasing dialysate temperature and reducing dialysate flow rate - Impact on solute clearance and a strategy for water conservation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
sakthirajan ramanathan |
| Designation |
Assistant Professor |
| Affiliation |
madras medical college |
| Address |
Block-2 , 3H, Ramaniyam kamadhenu appts, ponnambalam salai, K.K.Nagar
Madras Medical College
E.V.R.Periyar salai, chennai 600003
Chennai
TAMIL NADU
600078
India |
| Phone |
09444126080 |
| Fax |
|
| Email |
draatral@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
sakthirajan ramanathan |
| Designation |
Assistant Professor |
| Affiliation |
madras medical college |
| Address |
Block-2 , 3H, Ramaniyam kamadhenu appts, ponnambalam salai, K.K.Nagar
Madras Medical College,
E.V.R.Periyar salai, chennai 600003
Chennai
TAMIL NADU
600078
India |
| Phone |
09444126080 |
| Fax |
|
| Email |
draatral@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dolphin solomon J |
| Designation |
senior resident |
| Affiliation |
madras medical college |
| Address |
Madras Medical College,
E.V.R.Periyar salai, chennai 600003
Madras Medical College,
E.V.R.Periyar salai, chennai 600003
Chennai
TAMIL NADU
600003
India |
| Phone |
09444126080 |
| Fax |
|
| Email |
mmcnephro@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Director Institute of Nephrology Madras Medical College |
| Address |
Institute of Nephrology, Madras Medical College, chennai 600003 |
| Type of Sponsor |
Government medical college |
|
|
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 Sakthirajan R |
Madras Medical College |
Institute of Nephrology, New Renal Block First floor, Room no : 102,E.V.R.PERIYAR salai, Chennai - 600003
Chennai
TAMIL NADU |
09444126080
draatral@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| madras medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Increasing the Dialysate temperature to 38.5 degree centigrade and reducing the dialysate flow to 300 ml per minute |
Increasing the Dialysate temperature from 37 degree to 38.5 degree centigrade and reducing the dialysate flow from 500 ml per minute to 300 ml per minute in every session of hemodialysis |
| Comparator Agent |
keeping the dialysate temperature at 37 degree centigrade and dialysate flow rate at 500 ml per minute |
keeping the dialysate temperature at 37 degree centigrade and dialysate flow rate at 500 ml per minute in very session of Hemodialysis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with well functioning AVFistula. 2.Dialysis vintage more than 3 months.
3.No previous episodes of recurrent intradialytic hypotension.
4.left ventricle Ejection fraction > 40%.
|
|
| ExclusionCriteria |
| Details |
1.Patients with tunneled or non tunneled catheters as the dialysis access.
2.Patients with recurrent intradialytic hypotension.
3.Patients with autonomic neuropathy.
4.Patients with left ventricle Ejection fraction˂40%.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Urea reduction ratio in every session of hemodialysis.
2. calculation of online Kt/V and time to reach the target of 1.2 in every session of dialysis. |
one month each for intervention and comparator arm that includes 8 to 12 session of hemodialysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. number of episodes of intradialytic hypotension |
one month each for intervention and comparator arm that includes 8 to 12 session of hemodialysis |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/01/2022 |
| Date of Study Completion (India) |
31/05/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [draatral@gmail.com].
- For how long will this data be available start date provided 24-10-2022 and end date provided 24-10-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study aims to find out the impact on solute clearance and ability to achieve adequate dialysis by increasing the dialysate temperature from 37 to 38.5 degree centigrade and reducing dialysate flow from 500 ml to 300 ml per minute - as a strategy for conservation of water in hemodialysis. End stage kidney disease patients who are on hemodialysis for more than three months and of age between 18 and 65 years with good functioning arterio venous fistula , with no evidence of recurrent intradialytic hypotension and left ventricular ejection fraction more than 40 % will be included. Those who are on tunneled or non tunneled catheter as access , who had recurrent intradialytic hypotension, those with autonomic neuropathy and left ventricle ejection fraction less than 40 % will be excluded. This is a non randomised single arm open labelled cross over trial. A sample of 30 patients will be given dialysis with a dialysate temperature of 37 degree and flow of 500 ml per minute for first month followed by same set of patients subjected to the intervention of increasing the dialysate temperature to 38.5 degree and reducing the flow to 300 ml per minute. Primary outcome will be calculation of urea reduction ratio and time to achieve online Kt/V of 1.2 at the end of each dialysis session for total of 8 to 12 session during the control period and intervention period. secondary outcome is recording the number of episodes of intradialytic hypotension during both the period. |