| CTRI Number |
CTRI/2025/01/079659 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Single center, observational ambispective study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study of various dialysis modalities in acute kidney injury in critically ill children. |
|
Scientific Title of Study
|
A single center, observational study of renal replacement therapy in acute kidney injury in critically ill children |
| 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 Mamta N Muranjan |
| Designation |
Professor, Pediatrics,Seth G.S. Medical College and KEM Hospital,Mumbai |
| Affiliation |
Seth G.S. Medical College and KEM Hospital |
| Address |
Department of Pediatrics,Seth G.S. Medical College and KEM Hospital,Parel,Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920209036 |
| Fax |
|
| Email |
muranjanmamta@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nayan Utpal |
| Designation |
Junior Resident,Department of Pediatrics,Seth G.S. Medical College and KEM Hospital,Parel,Mumbai |
| Affiliation |
Seth G.S. Medical College and KEM Hospital |
| Address |
Department of Pediatrics,Seth G.S. Medical College and KEM Hospital,Parel,Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8789818294 |
| Fax |
|
| Email |
nayanutpal1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamta N Muranjan |
| Designation |
Professor, Pediatrics,Seth G.S. Medical College and KEM Hospital,Mumbai |
| Affiliation |
Seth G.S. medical college and KEM Hospital |
| Address |
Department of Pediatrics,Seth GS Medical College and KEM Hospital,Parel,Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9920209036 |
| Fax |
|
| Email |
muranjanmamta@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatrics and Department of Nephrology,Seth G.S. Medical College and KEM Hospital,Parel,Mumbai,PIN Code- 400012,India |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM hospital |
| Address |
Seth G.S. Medical College and KEM Hospital,Parel,Mumbai, PIN code 400012,India |
| 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 Mamta N Muranjan |
KEM Hospital |
Department of Pediatrics,Seth G.S. Medical College and KEM Hospital,Parel,Mumbai,PIN code 400012,India
Mumbai
MAHARASHTRA |
9920209036
muranjanmamta@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -III,Seth GS medical college and KEM hospital,Mumbai,Maharashtra,Mumbai |
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 |
| Comparator Agent |
Renal Replacement Therapy |
Renal Replacement Therapy in form of Peritoneal Dialysis or Hemodialysis in critically ill children with AKI |
|
|
Inclusion Criteria
|
| Age From |
28.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Infants and children,having AKI and undergoing renal replacement therapy will be included,only if the parents/patients are willing to participate |
|
| ExclusionCriteria |
| Details |
Patients who have received renal replacement therapy in another institute and are recovering during their stay at study site will be excluded and patients with end stage renal disease esta blished on RRT will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will comprehensively document and analyze the management of AKI patients requiring renal replacement therapy in PICU. |
Data will be analyzed at the end of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will document morbidity and mortality of critically ill children with AKI |
At the end of the study |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/02/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 observational study focuses on renal replacement therapy (RRT) in critically ill children with acute kidney injury (AKI), utilizing a single-center approach to examine clinical outcomes and management strategies. AKI, characterized by acute renal failure lasting hours to days, poses significant challenges in pediatric intensive care, affecting approximately 5% of hospitalized children and 32% of those in pediatric intensive care units. Renal replacement therapies such as hemodialysis (HD) and peritoneal dialysis (PD) play critical roles in managing severe cases, addressing complications like refractory hyperkalemia, oliguria, acidosis, and uremia. The study aims to explore the efficacy and safety profiles of different RRT modalities, including HD variants like continuous renal replacement therapy (CRRT) and sustained low-efficiency dialysis (SLED). It seeks to identify predictors of survival and renal recovery in severe AKI (stage 3) among pediatric patients, considering factors such as underlying conditions, sepsis, electrolyte imbalances, and mechanical ventilation requirements. Methodologically, the study employs an ambispective observational design, integrating prospective and retrospective data over a period of 3 years, with a targeted enrollment of 70 participants. Ethical considerations ensure adherence to institutional guidelines, including informed consent and patient confidentiality. Data collection encompasses detailed clinical parameters, RRT specifics, and outcomes such as mortality rates and renal function recovery post-treatment. Statistical analyses will encompass descriptive statistics to profile the study cohort, comparative analyses of RRT modalities, survival analysis using Kaplan-Meier curves, and subgroup analyses to explore treatment effect modifiers. This comprehensive approach aims to yield insights into optimizing RRT practices and improving outcomes for critically ill children with AKI, ultimately informing evidence-based guidelines and enhancing pediatric nephrology care strategies. |