| CTRI Number |
CTRI/2025/02/080667 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of memory and thinking problems in chronic kidney disease patients and identification of possible risk factors |
|
Scientific Title of Study
|
Prevalence and risk factors of cognitive impairment in chronic kidney disease patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishnu Sarath |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department Of Nephrology, OPD building, Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9847391128 |
| Fax |
|
| Email |
vishnusarath59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indu R Rao |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department Of Nephrology, OPD building, Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9592896393 |
| Fax |
|
| Email |
indu.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Indu R Rao |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department Of Nephrology, OPD building, Kasturba Hospital, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9592896393 |
| Fax |
|
| Email |
indu.rao@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital , Madhav Nagar, Manipal ,Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Vishnu Sarath |
| Address |
Department of Nephrology, OPD building, Kasturba Hospital, Madhav Nagar, Manipal, Karnataka, 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 Vishnu Sarath |
Kasturba Hospital |
Room No 15, Department Of Nephrology, OPD building, Kasturba hospital, Madhav Nagar, Manipal, Karnataka, 576104
Udupi
KARNATAKA |
9847391128
vishnusarath59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical college and Kasturba Hospital Institutional Ethics Committee 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N184||Chronic kidney disease, stage 4 (severe), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who belong to chronic kidney disease
stage3- stage 5 non dialysis patients |
|
| ExclusionCriteria |
| Details |
1.Patients less than 18 years of age
2.Patients who are not giving consent to the study
3.Patients who had head injury, neurological
disorders, encephalopathy.
4.Patients taking psychiatric drugs and other
drugs that interfere with cognitive functioning
5.Terminally ill patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of cognitive impairment in chronic kidney disease patients using MoCA score |
Outcome will be assessed only at baseline when the patient is recruited. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Risk factors for cognitive impairment in chronic kidney disease patients |
outcome will be assessed only at baseline when the patient is recruited |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
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)
|
01/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cognitive impairment has been reported from early stage chronic kidney disease patients. Prevalence of cognitive impairment in chronic kidney disease patients is 20% to 50% and up to 70 % in older patients on dialysis In everyday practice cognitive impairment in chronic kidney disease patients is still underdiagnosed, underreported and undertreated. This research project aims to address these issues. Patients will be included in the study as per inclusion criteria. MoCA test will be administered for each patient and a score of 26 and above will be considered normal and any score below 26 will be considered as cognitive impairment. Total score of 18-25 will be considered as mild cognitive impairment, 10-17 as moderate cognitive impairment and less than 10 as severe cognitive impairment. Variables included in the study age, gender, marital status, years of schooling schooling, alcohol use ,smoking, presence of comorbidities including hypertension, type 2 diabetes mellitus, hypothyroidism and cardiovascular disease. These variables will be analysed as possible risk factors for development of cognitive impairment |