| CTRI Number |
CTRI/2022/01/039143 [Registered on: 04/01/2022] Trial Registered Prospectively |
| Last Modified On: |
04/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence and factors associated with itching in hemodialysis patients and its influence on their health related quality of life and sleep |
|
Scientific Title of Study
|
Uremic Pruritus: Prevalence, Factors Associated, Its Influence On Health Related Quality Of Life And Sleep In Individuals On Maintenance Hemodialysis At A Tertiary Care Hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DEEKSHA |
| Designation |
PG STUDENT |
| Affiliation |
MANIPAL COLLEGE OF HEALTH PROFESSIONS |
| Address |
RENAL REPLACEMENT THERAPY AND DIALYSIS TECHNOLOGY PROGRAMME,
MANIPAL COLLEGE OF HEALTH PROFESSIONS,
MANIPAL ACADEMY OF HIGHER EDUCATION,
MANIPAL,
UDUPI.
KARNATAKA.
Udupi
KARNATAKA
576104
India |
| Phone |
9740354191 |
| Fax |
|
| Email |
deeksha.mcoahsma17@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MOHAN V BHOJARAJA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF NEPHROLOGY,
KASTURBA MEDICAL COLLEGE,
KASTURBA HOSPITAL,
MANIPAL ACADEMY OF HIGHER EDUCATION,
MANIPAL,
UDUPI
KARNATAKA.
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR MOHAN V BHOJARAJA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF NEPHROLOGY,
KASTURBA MEDICAL COLLEGE,
KASTURBA HOSPITAL,
MANIPAL ACADEMY OF HIGHER EDUCATION,
MANIPAL,
UDUPI
KARNATAKA.
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College & Kasturba Hospital, Manipal- 576104 |
|
|
Primary Sponsor
|
| Name |
Deeksha |
| Address |
Hemodialysis unit
Kasturba Medical College & 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 |
| DR MOHAN V BHOJARAJA |
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL |
HEMODIALYSIS UNIT, DEPARTMENT OF NEPHROLOGY,
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL, MANIPAL
Udupi
KARNATAKA |
9902548725
mohan.vb@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 |
| Healthy Human Volunteers |
To be able to understand & sign the informed consent form. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged >18 years on Maintenance hemodialysis for > 3 months.
|
|
| ExclusionCriteria |
| Details |
Patients on peritoneal dialysis.
Skin diseases other than uremic pruritus.
AKI patients.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Prevalence of uremic pruritus among maintenance hemodialysis patients in a tertiary care hospital
|
1 week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of risk factors |
1 week |
| Intensity of uremic pruritus - (12 Point PSS score) |
1 week |
| Effect on Health related Quality of Life (SKINDEX-10 score) |
1 week |
| Sleep Quality (Itch MOS (of sleep) score) |
1 week |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
05/01/2022 |
| 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="0"
Months="3"
Days="0" |
|
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
|
Uremic pruritus is commonly seen in advanced Chronic Kidney Disease (CKD) patients. This study is performed to know the prevalence of uremic pruritus among maintenance hemodialysis patients in a tertiary care hospital. And also to know its association with certain risk factors such as anemia, CKD- MBD (Chronic Kidney Disease- Mineral Bone Disorder) and dialysis related risk factors in patients on maintenance hemodialysis. Uremic pruritus , often, might affect the social interactions, hindering work, and disturb the sleep cycle & its quality, etc., which might decrease the quality of life & sleep quality in such patients. By the end of this study we aim to know the prevalence of uremic pruritus among maintenance hemodialysis patients in a tertiary care hospital & to identify the health related quality of life & the quality of sleep will be assessed by using certain questionnaires. . |