| CTRI Number |
CTRI/2024/04/065121 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
CLinical Evaluation of Renal Failure in a Hospital |
|
Scientific Title of Study
|
Clinico Biochemical And Etiological Profile of Chronic Kidney Disease In A Tertiary Care Centre |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kadire Mani Deep Reddy |
| Designation |
PG Student |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department Of General Medicine Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9550648326 |
| Fax |
|
| Email |
manideep333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubha Seshadri |
| Designation |
Professor And Head Of Unit |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department Of General Medicine Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845563799 |
| Fax |
|
| Email |
shubha.seshadri@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubha Seshadri |
| Designation |
Professor And Head Of Unit |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department Of General Medicine Kasturba Medical College Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845563799 |
| Fax |
|
| Email |
shubha.seshadri@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba Medical College Manipal Karnataka 576104 |
| Type of Sponsor |
Private 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 Mani Deep Reddy |
Kasturba Hospital, Manipal |
Department Of General Medicine, Department Of Nephrology, Kasturba Hospital, Madhava Nagar, Manipal
Udupi
KARNATAKA |
09550648326
manideep333@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Kasturba Medical College |
Approved |
| KASTURBA MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
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 |
Patients With Gfr Less than 60 ml/min/1.73 m2 For More Than 3 Months On The Basis Of Estimated Gfr Using The Ckdepi Equation.
Patients Diagnosed Newly With Chronic Kidney Disease
Chronic Kidney Disease Patients Already Either On Medical Management/renal Replacement Therapy.
|
|
| ExclusionCriteria |
| Details |
Patients With Acute Illness
Patients Who Had Undergone Renal Transplant
Patients With Malignancies
Patients With Liver Disorders
Patients Denying Consent |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study The Various Causes, Risk Factors of Chronic Kidney Disease Among Various Age Groups |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Study The Complications Of Chronic Kidney Disease In Various Age Groups |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/04/2024 |
| 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="6"
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
|
Need Of The Study The Importance Of CKD And Its Risk Factors Is Due To Its Increasing Prevalence, CKD related CVD,ESRD , And The Consequent Financial Burden Of Renal Replacement Therapy.Screening And Intervention Can Prevent CKD. And Management Strategies Can Be Implemented To Reduce The Incidence Of ESRD.
Description Of The Study Patients Will Be Selected Based On The Above Mentioned Criteria And Are Recruited Into The Study After Taking Consent. The Diagnosis Of And Staging Of Chronic Kidney Disease Will Be Made As Per Kidney Disease Improving Global Outcome Classification And Estimated Glomerular Filtration Rate Will Be Calculated Using CKD-EPI Formula. Informed Consent Will Be Obtained From All The Subjects. The Case History Shall Be Recorded On A Proforma. Data On Age, Sex, Education, Occupation And Smoking Will Be Collected From All Subjects. Family History Regarding CKD Shall Be Noted. Medical History Will Be Obtained Regarding Presenting Complaints Which Includes Anorexia, Nausea, Vomiting, Breathlessness, Pruritus, Altered Sensorium, Convulsions, Polyuria And Dysuria. All Subjects Are Interviewed Regarding Past History Of Diabetes, Hypertension And Other Co-morbid Conditions. General Examination Shall Be Done Assessing Pallor, Pedal Edema, Abdominal Distension And Flaps. |