| CTRI Number |
CTRI/2026/02/104569 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“Protecting Children’s Kidneys During Heart Surgery: How Amino Acids May Help” |
|
Scientific Title of Study
|
Intravenous amino acid therapy for kidney protection in pediatric patients undergoing cardiac surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jigyasa Bharti |
| Designation |
SR |
| Affiliation |
PGIMER, Chandigarh |
| Address |
54 S.A.S Nagar Extension Jalandhar Punjab
Jalandhar
PUNJAB
144003
India |
| Phone |
7696349779 |
| Fax |
|
| Email |
jigyasabharti522@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ira Dhawan |
| Designation |
Assistant professor |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
Pgimer, chandigarh
Chandigarh
CHANDIGARH
166012
India |
| Phone |
|
| Fax |
|
| Email |
driradhawan14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jigyasa bharti |
| Designation |
Senior resident |
| Affiliation |
Post graduate institute of medical education and research |
| Address |
405 sector 37A chandigarh
PGIMER sector 12 chandigarh
Chandigarh
CHANDIGARH
160036
India |
| Phone |
07696349779 |
| Fax |
|
| Email |
jigyasabharti522@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER chandigarh, India 166012 |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of medical education and research |
| Address |
PGIMER Sector 12 Chandigarh India 1660012 |
| Type of Sponsor |
Government 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 |
| Dr Jigyasa bharti |
Post graduate institute of medical education and research |
CTVS, 4th floor, advanced cardiac centre
Chandigarh
CHANDIGARH |
07696349779
jigyasabharti522@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Infants and children with age group upto 5 years with congenital heart disease who underwent surgical palliation or correction with cardiopulmonary bypass
informed consent for surgery not given by parents/guardians |
|
| ExclusionCriteria |
| Details |
neonates with AKI
Preexisting chronic kidney disease and end stage kidney disease
Premature babies
use of ACE inhibitors preoperatively
informed consent for surgery not given by parents/guardians |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| occurence of AKI within the first week after surgery with AKI defined according to the KDIGO creatinine criteria |
serum urea and creatinine at 24 hours, 48 hours, 72 hours and after 7 days postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
severity of AKI
use & duration of kidney replacement therapy during hospital stay
duration of mechanical ventilation
ICU stay
Hospital stay
Mortality |
at 24hour 48 hour 72 hour 7th postoperative day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/03/2026 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jigyasabharti522@gmail.com].
- For how long will this data be available start date provided 31-12-2026 and end date provided 30-06-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
we hypothesized that an infusion of amino acids commenced before exposure to CPB intraoperatively and continue for 72 hours postoperatively in pediatric population undergoing complex cardiac surgeries, may help maintain renal blood flow, thus ameliorating the ischemic and inflammatory injury that contributes towards the onset of cardiac surgery associated AKI. we conducted this study to test this hypothesis. patients were randomly allocated to standard care or to commence an infusion of amino acids after induction of anesthesia and before exposure to CPB intraoperatively and continued for 72 hours postoperatively |