| CTRI Number |
CTRI/2025/09/094862 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Safety and Effectiveness of Regional Citrate Anticoagulation in Children Undergoing Continuous Kidney Support in Critically Ill Children. |
|
Scientific Title of Study
|
Safety and Efficacy of Regional Citrate Anticoagulation in Pediatric CRRT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashkumar Prajapati |
| Designation |
Postgraduation Resident |
| Affiliation |
INDRAPRASTHA APOLLO HOSPITAL |
| Address |
8 Shyam 36, Madhav Farm Road, Vastral, Ahmedabad, Gujarat
381-Pocket B, Sarita vihar, new delhi-110076
New Delhi
DELHI
382418
India |
| Phone |
9725264556 |
| Fax |
|
| Email |
yashprajapati6277@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Bagga |
| Designation |
Director of Pediatrics |
| Affiliation |
INDRAPRASTHA APOLLO HOSPITAL |
| Address |
B-14, Madhuvan, Delhi.
B-14, Madhuvan, Delhi
New Delhi
DELHI
110092
India |
| Phone |
9810590809 |
| Fax |
|
| Email |
arvindbagga@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arvind Bagga |
| Designation |
Director of Pediatrics |
| Affiliation |
INDRAPRASTHA APOLLO HOSPITAL |
| Address |
B-14, Madhuvan, Delhi
B-14, Madhuvan, Delhi
New Delhi
DELHI
110092
India |
| Phone |
9810590809 |
| Fax |
|
| Email |
arvindbagga@hotmail.com |
|
|
Source of Monetary or Material Support
|
| INDRAPRASTHA APOLLO HOSPITAL
NH-19, Jasola Vihar, New Delhi, Delhi 110076,
India. |
|
|
Primary Sponsor
|
| Name |
Dr Yashkumar Prajapati |
| Address |
8 Shyam 36, Reliance Petrol Pump Pachal, Madhav Farm Road, Vastral, Ahmedabad, Gujarat-382418,
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 YASHKUMAR PRAJAPATI |
INDRAPRASTHA APOLLO HOSPITAL |
NH-19, Jasola Vihar-110076, New Delhi
New Delhi
DELHI |
9725264556
yashprajapati6277@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE- BIOMEDICAL RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K720||Acute and subacute hepatic failure, (2) ICD-10 Condition: E877||Fluid overload, (3) ICD-10 Condition: E889||Metabolic disorder, unspecified, (4) ICD-10 Condition: N178||Other acute kidney failure, (5) ICD-10 Condition: E878||Other disorders of electrolyte andfluid balance, not elsewhere classified, (6) ICD-10 Condition: E883||Tumor lysis syndrome, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Pediatric patient who require continuous renal replacement therapy (CRRT) with regional citrate anticoagulation (RCA). |
|
| ExclusionCriteria |
| Details |
(1) Patients are already on systemic anticoagulation, such as heparin or warfarin.
(2) Known inherited or acquired disorders of calcium or citrate metabolism, e.g. primary hypoparathyroidism, mitochondrial citrate transport defects.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine proportion of patients showing survival of CRRT circuit. |
At 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine survival of CRRT circuit without citrate accumulation. |
At 72 hours |
| To measure incidence of severe bleeding, electrolyte imbalance, metabolic acidosis. |
Within 72 hours |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
29/09/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Continuous Renal Replacement Therapy (CRRT) is widely used in critically ill children for various indications such as acute kidney injury and other variation conditions. Anticoagulation is essential to maintain circuit function during CRRT, with regional citrate anticoagulation (RCA) and systemic heparin being the primary methods. RCA is preferred in many cases due to lower bleeding risk and longer circuit life, especially in adult patients. However, evidence on its use in children is limited. This study aims to evaluate the safety and efficacy of RCA in pediatric patients undergoing CRRT at this center. |