| CTRI Number |
CTRI/2023/07/054996 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The incidence of Kidney Injury in neonates with heart diseases using Serum Creatinine and Serum Cystatin C |
|
Scientific Title of Study
|
The incidence of Acute Kidney Injury in neonates with Congenital Heart Disease in a tertiary care hospital over a period of one year |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Roshni |
| Designation |
MD Paediatrics |
| Affiliation |
Department of Paediatrics, JNMC, Belgaum |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
8940885116 |
| Fax |
|
| Email |
rrosh2009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahantesh V Patil |
| Designation |
Professor |
| Affiliation |
Division of Paediatric Nephrology, Department of Paediatrics, JNMC, Belgaum |
| Address |
Division of Paediatric Nephrology, Jawaharlal Nehru Medical College, Belgaum
Division of Paediatric Nephrology, Jawaharlal Nehru Medical College, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9483561674 |
| Fax |
|
| Email |
patilmv1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Roshni |
| Designation |
MD Paediatrics |
| Affiliation |
Department of Paediatrics, JNMC, Belgaum |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
8940885116 |
| Fax |
|
| Email |
rrosh2009@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College,Nehru Nagar, Belgaum 590010 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Department of Paediatrics, Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum 590010 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| R Roshni |
KLEs Dr Prabhakar Kore Hospital and Medical Research Centre |
Department of Paediatrics
Belgaum
KARNATAKA |
8940885116
rrosh2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JNMC Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q219||Congenital malformation of cardiacseptum, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Neonates with congenital heart disease |
|
| ExclusionCriteria |
| Details |
Neonates with renal anomalies
Operated cases of congenital heart disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare serum creatinine & serum cystatin c in detecting early Acute Kidney Injury in neonates with Congenital Heart Disease |
The study will be conducted over a span of one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of early acute kidney injury in neonates with congenital heart disease using serum creatinine & serum cystatin C |
The study will be conducted over a span of one year |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
22/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/07/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The neonatal acute kidney injury is a common occurrence in neonatal intensive care unit requiring prompt diagnosis and treatment which is challenging in our country. Neonatal acute kidney injury itself is an independent risk factor for mortality and associated with adverse outcomes requiring long term follow up. Hence this study aime to study the incidence of acute kidney injury in neonates with congenital heart disease and it’s risk factors and outcomes using serum creatinine and serum cystatin C |