| CTRI Number |
CTRI/2021/01/030764 [Registered on: 27/01/2021] Trial Registered Prospectively |
| Last Modified On: |
25/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of life in end stage renal disease patients on hemodialysis. |
|
Scientific Title of Study
|
Clinical profile and Quality of Life in Incident Hemodialysis Patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Insha Firoz |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Department of Renal Replacement Therapy and Dialysis Technology, Manipal College of Health Professions, MAHE, Manipal.
Department of Nephrology, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8077400307 |
| Fax |
|
| Email |
insha.firoz@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Prabhu |
| Designation |
Professor and Unit Head |
| Affiliation |
MBBS, MD (Medicine) DM (Nephrology) DNB |
| Address |
Department of Nephrology KMC Manipal 576104
Department of Nephrology Kasturba Hospital Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9448107771 |
| Fax |
|
| Email |
ravindra.prabhu@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Insha Firoz |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Health Professions, MAHE, Manipal |
| Address |
Department of Renal Replacement Therapy and Dialysis Technology, Manipal College of Health Professions, MAHE, Manipal.
Department of Nephrology, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8077400307 |
| Fax |
|
| Email |
insha.firoz@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Nephrology, Kasturba Hospital, Manipal 576104 |
|
|
Primary Sponsor
|
| Name |
Insha Firoz |
| Address |
Department of Nephrology, Kasturba Hospital, Manipal 576104 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Insha |
Kasturba hospital, KMC, Manipal 576104 |
Department of Nephrology, Dialysis unit 3rd floor.
Udupi
KARNATAKA |
8077400307
insha.firoz@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z992||Dependence on renal dialysis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients >18 years initiated hemodialysis in January 2018 to December 2019. |
|
| ExclusionCriteria |
| Details |
Patients in which informed consent cannot be obtained.
peritoneal dialysis patients.
neurological disorder patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| health related quality of life score. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| factors affecting quality of life. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/01/2021 |
| 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="1"
Months="2"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
With the help of this study we will assess the kidney disease burden symptoms in hemodialysis patients. As in India there is limited data on quality of life in hemodialysis patients hence this study is important. |