| CTRI Number |
CTRI/2026/03/106051 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study on patients with acute kidney injury requiring dialysis |
|
Scientific Title of Study
|
An observational prospective study on the clinical profile and outcomes of patients admitted with acute kidney injury requiring dialysis |
| 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 Shubham Patel |
| Designation |
JR3 Under department of general medicine |
| Affiliation |
DR D Y patil medical college,Navi Mumbai,thane |
| Address |
department of general medicine DR D Y patil medical college,Navi Mumbai,thane
Thane
MAHARASHTRA
400706
India |
| Phone |
9099234888 |
| Fax |
|
| Email |
shubhy9091@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arundhati barua |
| Designation |
Professor and HOU General medicine |
| Affiliation |
DR D Y patil medical college,Navi Mumbai,thane |
| Address |
department of general medicine DR D Y patil medical college,Navi Mumbai,thane
Thane
MAHARASHTRA
400706
India |
| Phone |
9819192212 |
| Fax |
|
| Email |
Arundhati.barua@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Patel |
| Designation |
Junior Resident |
| Affiliation |
DR D Y patil medical college,Navi Mumbai,thane |
| Address |
Department of general medicine DR D Y patil medical college,Navi Mumbai,thane
Thane
MAHARASHTRA
400706
India |
| Phone |
9099234888 |
| Fax |
|
| Email |
shubhy9091@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y patil Medical College and Hospital,Nerul,Navi Mumbai,Maharashtra,India,400706 |
|
|
Primary Sponsor
|
| Name |
Dr Shubham patel |
| Address |
Department of general medicine,Dr D Y patil medical college,Navi mumbai |
| Type of Sponsor |
Other [Primary investigator] |
|
|
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 Shubham patel |
DR D Y patil medical college |
OPD-1 (General Medicine),Medical ICU,Dialysis room,NEPHROLOGY OPD
Thane
MAHARASHTRA |
9099234888
shubhy9091@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethics committee for biomedical and health reasearch(IECBH)Dr D Y Patil Medical college andhospital,Navi mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N17-N19||Acute kidney failure and chronic kidney disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients not having CKD |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome assessment at three months of patients with Acute kidney injury requiring dialysis |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/04/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Outcome assessment at three months of patients with Acute Kidney Injury requiring dialysis To study outcome of acute kidney injury (AKI) i.e Mortality Rate, Complete Recovery (Cr), Partial Recovery , And Necessitating Hemodialysis |