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CTRI Number  CTRI/2024/10/076080 [Registered on: 30/10/2024] Trial Registered Prospectively
Last Modified On: 30/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective study of retrospectively collected data 
Study Design  Other 
Public Title of Study   Understanding Treatment Phase at ICU Admission in Children with Blood Cancers 
Scientific Title of Study   Implications of Phase of treatment at ICU admission in critically ill children with haematological malignancy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4396_Protocol Version 1.1 dated 12 Jun 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sudivya Sharma 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain Tata Memorial Centre Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9892762615  
Fax    
Email  drsudivyasharma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudivya Sharma 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain Tata Memorial Centre Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9892762615  
Fax    
Email  drsudivyasharma@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sudivya Sharma 
Designation  Professor 
Affiliation  Tata Memorial Hospital 
Address  Department of Anesthesia Critical care and Pain Tata Memorial Centre Dr E Borges Road Parel Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9892762615  
Fax    
Email  drsudivyasharma@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Mumbai 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Tata Memorial Centre, Dr. E Borges Road, Parel, Mumbai - 400 012 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr SUDIVYA SHARMA  Tata Memorial Hospital  Dept. of Anaesthesia, Critical Care and Pain, Major OT complex, Second Floor, Main Building, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
9892762615

drsudivyasharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Memorial Hospital Institutional Ethics Committee II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  NA 
Comparator Agent  Nil  NA 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children less than 18 years with provisional or under evaluation or confirmed diagnosis of acute leukemia AML and ALL admitted in Medical or Surgical ICU from January 2022 to December 2022 
 
ExclusionCriteria 
Details  Children admitted for supportive care those expected to die within 24 hours of ICU admission and patients admitted after a Blue code 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the mortality rate at various oncological stages of treatment in the acute leukaemia paediatric populations in an ICU setup of tertiary care cancer centre  Until ICU discharge and at 90 days of ICU admission  
 
Secondary Outcome  
Outcome  TimePoints 
- Length of stay
- 90-day survival and 1 year survival of children admitted at induction in ICU
- 90-day survival and 1 year survival of children admitted at other stages in ICU
- To determine the cause of death in ICU 
Until ICU discharge and at 90 days of ICU admission 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   13/11/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION-Leukaemia is the most common cancer in children. Three-fourth of these cases are acute lympoblastic leukaemia (ALL). The 5- year survival rate of ALL is around 90% and for acute myelogenous leukaemia (AML) is around 65-70%. Two-thirds of these children get admitted to the ICU for various reasons, the commonest being sepsis. Other common reasons for ICU admission are tumor lysis syndrome, respiratory failure, circulatory collapse, bleeding. Improving survival in pediatric haematological malignancies over the years can be attributed to newer and more aggressive administration of chemotherapeutic drugs, improvement in supportive care, identifying and treating children with fever and neutropenia, prevention of opportunistic infections and administration of blood products when necessary. ALL are risk stratified based on their age, presentation features, tumour genetics and treatment response. High risk includes B Cell Precursor-ALL patients with any high-risk feature, including high-risk genetics, central nervous system leukaemia, T-lineage ALL, poor response to prednisolone at treatment on day 8 and high MRD (≥ 0·01%) at the end of induction phase. AML are risk stratified based on age, cytogenetics, molecular features and treatment response.

HYPOTHESIS- The high morbidity and mortality in critically ill paediatric oncology patients stem from both aggressive cancer pathophysiology (organ infiltration and immunodeficiency) and intensive anti-neoplastic therapies, which can cause systemic toxicity. Haematological malignancies cause significant myelosuppression and the intensive phage of chemotherapy adds to the toxicity and this cohort has the highest risk of life threatening infections. Induction phase of leukaemia and lymphoma are part of high risk diagnosis in severity of illness scores and account for high resource utilization. In this study we want to evaluate the outcomes of children admitted to the ICU during various phases of treatments. This will help us guide decisions regarding triaging decisions and resource allocation.

METHODOLOGY-We aim to retrospectively analyse the data collected from Electronic Medical Records of patients less than 18 years, with provisional or confirmed diagnosis of acute leukaemia (AML, ALL) admitted to the ICU from January 2022 to December 2022, to understand the impact of the stage of treatment on the ICU outcomes.

STATISTICAL ANALYSIS- The statistical analysis plan encompasses descriptive statistics, survival analysis using Kaplan-Meier curves and log-rank tests, multivariate analyses employing Cox proportional hazards regression to adjust for confounders, stratified and subgroup analyses, as well as sensitivity analyses to ensure the robustness of the findings. Categorical variables (e.g., gender, oncological stage) will be represented in the form of frequencies and percentages and continuous variables (e.g., age, duration of ICU stay) will be represented as mean and standard deviations. Kaplan-Meier survival analysis will be done to determine the mortality rate at various oncological stages of treatment in the acute leukaemia paediatric populations in an ICU. Log-rank test will be done to compare survival curves between different oncological stages.Multivariate Analysis will be done using Cox proportional hazards regression model to assess the impact of the oncological stage and other relevant variables such as severity and duration of neutropenia, severity of illness scores (PRISM 3/PIM3), SOFA, need for ventilation, need for vasopressors, need for RRT, etc., on mortality.

 
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