| CTRI Number |
CTRI/2026/03/106492 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of role of clinical and laboratory parameters in initiating hemodialysis in patients with chronic kidney disease |
|
Scientific Title of Study
|
Study of association of clinical characteristics and inflammatory markers with hemodialysis in patients with chronic kidney disease (CKD) in tertiary healthcare centre and teaching hospital in Western Maharashtra: Observational, analytical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubhangi Dhadke |
| Designation |
Associate Professor |
| Affiliation |
Dr. V. M. Govt. Medical College |
| Address |
Department of Medicine,
Dr. V. M. Govt. Medical College,
Solapur, Maharashtra 413003
Solapur
MAHARASHTRA
413003
India |
| Phone |
9421032257 |
| Fax |
|
| Email |
shubhangidhadke1969@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shubhangi Dhadke |
| Designation |
Associate Professor |
| Affiliation |
Dr. V. M. Govt. Medical College |
| Address |
Department of Medicine,
Dr. V. M. Govt. Medical College,
Solapur, Maharashtra 413003
Solapur
MAHARASHTRA
413003
India |
| Phone |
9421032257 |
| Fax |
|
| Email |
shubhangidhadke1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhangi Dhadke |
| Designation |
Associate Professor |
| Affiliation |
Dr. V. M. Govt. Medical College |
| Address |
Department of Medicine,
Dr. V. M. Govt. Medical College,
Solapur, Maharashtra 413003
Solapur
MAHARASHTRA
413003
India |
| Phone |
9421032257 |
| Fax |
|
| Email |
shubhangidhadke1969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. V. M. Govt. Medical College, Solapur, Maharashtra 413003
|
|
|
Primary Sponsor
|
| Name |
Shubhangi V. Dhadke |
| Address |
Dr. V. M. Govt. Medical College, Solapur, Maharashtra 413003
|
| 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 Shubhangi Dhadke |
Department of Medicine, Dr. Vaishampayan Memorial Government Medical College, Solapur |
Department of Medicine, Dr. V. M. Govt. Medical College, Solapur, Maharashtra 413003 India
Solapur
MAHARASHTRA |
9421032257
shubhangidhadke1969@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. VMGMC Institutional Ethics Committee |
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 |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with chronic kidney disease |
|
| ExclusionCriteria |
| Details |
Patients less than 18 years
Patients greater than 80 years of age
Pregnant and lactating women
Patients not consenting participation in the study
Patients with acute kidney injury with no prior history of chronic kidney disease
Patients already receiving any form of dialysis
Patients in whom vascular access can not be secured
Patients with kidney transplant
Patients with urinary tract infections and urologic malignancies
Patients with acute and chronic infections
Patients with acute and chronic inflammatory conditions
Patients with malignancies, hematological diseases, HIV/AIDS, and other immunodeficiency states
Patients prescribed with steroid/immunosuppressants, and chemotherapy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of clinical characteristics and inflammatory markers and their association with hemodialysis in patients with chronic kidney disease |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of inflammatory markers’ levels across stages of chronic kidney disease |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="171"
Sample Size from India="171"
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)
|
30/03/2026 |
| 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="10"
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
|
This study is an observational, analytical study that assesses the clinical characteristics and inflammatory markers and their association with hemodialysis in patients with chronic kidney disease in a single center tertiary care setting. All patients admitted with a diagnosis of chronic kidney disease who meet the pre-listed inclusion and exclusion criteria and are willing to participate will be interviewed, examined, and investigated. The outcome of this study is comparison of clinical characteristics and inflammatory markers and their association with hemodialysis in patients with chronic kidney disease. The secondary outcome is to compare inflammatory markers’ levels in different stages of chronic kidney disease. |