| CTRI Number |
CTRI/2024/10/075073 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Acute kidney injury in children: How often it happens and what causes it. |
|
Scientific Title of Study
|
To study the incidence and clinicoetiological profile of acute kidney injury among children admitted in emergency |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Surbhi kumari |
| Designation |
Post graduate 2nd year |
| Affiliation |
Maulana azad medical college and lok nayak hospital |
| Address |
Department of paediatrics,near special ward , lok nayak hospital, near delhi gate
mamc, near delhi gate,delhi
Central
DELHI
110002
India |
| Phone |
9773633136 |
| Fax |
|
| Email |
surbhi.lhmc.178@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Urmila Jhamb |
| Designation |
Director professor |
| Affiliation |
Maulana azad medical college and lok nayak hospital |
| Address |
Department of pediatrics, lok nayak hospital, Maulana azad medical college, near Delhi gate, Delhi
mamc, near delhi gate,delhi
Central
DELHI
110002
India |
| Phone |
9968604309 |
| Fax |
|
| Email |
ujhamb@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surbhi kumari |
| Designation |
Post graduate 2nd year |
| Affiliation |
Maulana azad medical college and lok nayak hospital |
| Address |
Department of Pediatrics, lok nayak hospital, Maulana azad medical college,near delhi gate
mamc, near delhi gate,delhi
Central
DELHI
110002
India |
| Phone |
9773633136 |
| Fax |
|
| Email |
surbhi.lhmc.178@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of pediatrics , Lok nayak hospital,maulana azad medical college, Near Delhi gate, Delhi - 110002, India |
|
|
Primary Sponsor
|
| Name |
Dr Surbhi kumari |
| Address |
Department of pediatrics , Lok nayak hospital,maulana azad medical college, Near Delhi gate, Delhi - 110002, India |
| 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 Surbhi Kumari |
Lok nayak hospital |
Ward 13A ,Department of pediatrics , Lok nayak hospital,maulana azad medical college, Near Delhi gate, Delhi
Central
DELHI |
9773633136
surbhi.lhmc.178@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N179||Acute kidney failure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children between 1 month to 12 years of age admitted to the pediatric emergency on a pre specified day of the week. |
|
| ExclusionCriteria |
| Details |
1.Known cases of chronic kidney injury
2. Patients coming for day care services to emergency or admitted for some investigation/injection or infusion
3. Repeat admissions with Acute kidney injury which have been enrolled earlier. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage of children coming to emergency with AKI |
At discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome of children with Acute kidney injury at the time of discharge |
At discharge |
Compare outcomes of patients with Acute kidney injury vs patients without Acute kidney injury at
discharge |
At discharge |
| Outcome of children with Acute kidney injury at 3 months follow up |
At 3 months |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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)
|
10/10/2024 |
| 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="0"
Months="11"
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 a Prospective Observational study comparing patients with AKI with non AKI patients . The primary outcome of the study is to determine the incidence of AKI, causes of AKI and to classify them according to the severity based on KDIGO criteria. The secondary outcomes of the study is to compare outcomes of patients with AKI VS NON AKI and to determine the outcome of children with AKI at discharge and 3 month of follow up.
|