| CTRI Number |
CTRI/2020/11/029197 [Registered on: 18/11/2020] Trial Registered Prospectively |
| Last Modified On: |
17/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
use of ultrasound for predicting renal failure |
|
Scientific Title of Study
|
Renal Doppler Resistive Index & Renal Angina Index in Predicting AKI in critically ill children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avinash Reddy |
| Designation |
PICU fellow |
| Affiliation |
rainbow childrens Hospital |
| Address |
2ND FLOOR , PICU,RAINBOW CHILDRENS HOSPITAL, RAOD NO 2, BANJARA HILLS, HYDERABAD
Hyderabad
TELANGANA
500034
India |
| Phone |
9994462078 |
| Fax |
|
| Email |
avinashreddy@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Avinash Reddy |
| Designation |
PICU fellow |
| Affiliation |
rainbow childrens Hospital |
| Address |
RAINBOW CHILDRENS HOSPITAL, ROAD NO 2, BANJARA HILLS, HYDERABAD
Hyderabad
TELANGANA
500034
India |
| Phone |
9994462078 |
| Fax |
|
| Email |
avinashreddy@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Avinash Reddy |
| Designation |
PICU fellow |
| Affiliation |
rainbow childrens Hospital |
| Address |
PICU, 2ND FLOOR, RAINBOW CHILDRENS HOSPITAL, ROAD NO 2, BANJARA HILLS HYDERABAD
Hyderabad
TELANGANA
500034
India |
| Phone |
9994462078 |
| Fax |
|
| Email |
avinashreddy@outlook.com |
|
|
Source of Monetary or Material Support
|
| Rainbow Childrens Hospital |
|
|
Primary Sponsor
|
| Name |
Rainbow Childrens Hospital |
| Address |
Road no 2 , Banjara hills Hyderabad |
| 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 |
| Avinash Reddy |
rainbow childrens Hospital |
road no 2 , Banjara Hills
Hyderabad
Hyderabad
TELANGANA |
9994462078
avinashreddy@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rainbow Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N19||Unspecified kidney failure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1) all critically ill patients(SOFA >4)
2)length of stay longer than 72 hrs
|
|
| ExclusionCriteria |
| Details |
1)renal artery disease
2)children with chronic kidney disease
3)cirrhosis with hepato renal syndrome
4)use of renin angiotensin aldosterone antagonists
5)AKI on renal replacement therapy
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| whether renal resistive index helps in predicting Acute kidney injury or not |
it will be acessed at the time of discharge of each patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| whether renal resistive index helps in early identification of Acute kidney injury |
renal resistive index acessed on first 3 days of admission |
|
|
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)
|
20/11/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
its is a prospective study done in rainbow childrens Hospital , banjara Hills Hyderabad. it is done over a period of 1 year . subjects are included based on the inclusion criteria and renal resistive index is done accordingly. renal resistive index is followed till day 3 . data is collected and analysed whether renal resistive index helps in predicting Acute kidney injury. |