| CTRI Number |
CTRI/2021/03/032188 [Registered on: 22/03/2021] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of predictors of dialysis requirements in acute kidney injury |
|
Scientific Title of Study
|
To Study the characteristics and outcome of patients with AKI (KDIGO 3) who did not receive RRT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rohan Pradeep Raghuwanshi |
| Designation |
Resident in Nephrology |
| Affiliation |
KEM Hospital, Pune |
| Address |
Dialysis Department, KEM Hospital, Sardar Moodliar Road, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8830473083 |
| Fax |
|
| Email |
rohan.raghuwanshi7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Valentine Lobo |
| Designation |
Consultant Nephrologist |
| Affiliation |
KEM Hospital, Pune |
| Address |
Dialysis Department,
KEM Hospital, Sardar Moodliar Road, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
09049232489 |
| Fax |
|
| Email |
valentinelobo702@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Valentine Lobo |
| Designation |
Consultant Nephrologist |
| Affiliation |
KEM Hospital, Pune |
| Address |
Dialysis Department,
KEM Hospital, Sardar Moodliar Road, Rasta Peth, Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
09049232489 |
| Fax |
|
| Email |
valentinelobo702@gmail.com |
|
|
Source of Monetary or Material Support
|
| KEM Hospital, Sardar Moodliar Road, Rasta Peth, Pune 411011 |
|
|
Primary Sponsor
|
| Name |
KEM Hospital Pune |
| Address |
KEM Hospital Renal Unit
Sardar Moodliar Road Rasta Peth Pune |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Rohan Raghuwanshi |
KEM Hospital |
Dialysis Department,
KEM Hospital, Sardar Moodliar Road, Rasta Peth, Pune
Pune
MAHARASHTRA |
09049232489
rohan.raghuwanshi7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KEM Hospital Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N170||Acute kidney failure with tubularnecrosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult (>18 years) patients with Acute Kidney Injury Stage 3 (by KDIGO staging) |
|
| ExclusionCriteria |
| Details |
1. Patients having an indication of dialysis on 1st consultation with nephrology
2. Obstructive Uropathy
3. Acute on Chronic kidney disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Need for dialysis therapy during follow up |
30 days from AKI 3 diagnosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mortality
Renal Recovery |
30 days from AKI 3 diagnosis |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/03/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A significant proportion of patients in intensive care units develop acute kidney injury (AKI) stage 3 (a form of severe and acute decrease in kidney function). About 50% of them will require dialysis therapy (an artificial way of clearing blood similar to natural kidneys). Less amount of data is available for the remaining 50% who do not require dialysis. Also, the factors predicting the need for dialysis in these patient are not well studied. So, this study aims to study the patient with AKI-3 who do not require dialysis in the first instance. The study will try to find the factors that can predict the requirement of dialysis in such patients. The study is observational type (i.e. no active intervention is being done as a part of the study) and involves only collection of information regarding age, gender, kidney function tests, daily urine output, daily fluid intake which are readily available. If the dialysis is required for any patient, it will be done as decided by the nephrologist attending the patient. The collected information will be processed using various statistical test to find the factors that predicted requirement of dialysis. |