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CTRI Number  CTRI/2024/10/076081 [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   Results of Cardiac Arrest in Pediatric Cancer Patients 
Scientific Title of Study   Outcomes of in-hospital cardiac arrest in paediatric oncology patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4388_Protocol Version 1.0 dated 18 Dec 2023  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 
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 I  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I469||Cardiac arrest, cause unspecified, (2) 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  All cardiac page received of children in hospital under 18 years of age 
 
ExclusionCriteria 
Details  Cardiac arrest in children while admitted in the ICU 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Survival at 90 days post cardiac arrest in paediatric oncology patients  at 90 days post cardiac arrest 
 
Secondary Outcome  
Outcome  TimePoints 
- Causes of arrest
- Impact of mortality and morbidity review meetings on number of in hospital cardiac arrests 
At ICU discharge  
 
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)   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- Cardiac page or code blue is an intensive care service, which once activated, mobilizes a dedicated team to the site of cardiac arrest with all the equipment required for resuscitation. Successful resuscitation requires early recognition, immediate action by the parent team till ICU team arrives, high quality advanced cardiac life support and cardiopulmonary resuscitation (CPR) and efficient transport to the ICU. The underlying pathology plays the most important role in determining the outcome of the child. This is the reason that many a times the revival at site does not transcend to survival at hospital discharge. This may reflect ill-sustained revival of organ function and irreversible damage setting in before, during or post cardiac arrest. To address cardiac page episodes and associated poor survival, we as a team, started Mortality Morbidity meetings (M&M) between paediatric oncologists and intensivists to review all deaths, 2 years back. These meetings are known to enhance professional learning, assure safe clinical practices, identify areas of improvement, and monitor quality of hospital care. The focus was on systematic process change and we ensured a non-judgmental environment. There are certain considerations unique to cancer setting. Sepsis is the biggest cause of morbidity and mortality in these immunocompromised children. Cancer being a specialized branch, patients travel from distant places causing delay in presentation. Frequent cardiac page is received from the casualty. Parents should be educated regarding warning signs. Lack of ‘do not resuscitate’ orders may allow CPR in unwarranted situations. Survival to in hospital cardiac arrest is 46% at discharge as per a recent systematic review. National registry of cardiopulmonary resuscitation in United States suggests 27% survival to discharge, but only 15.7% with good neurological outcome.Outcomes in hematology/oncology children are much inferior. We conducted M& M meetings monthly to enable in-depth discussion of such cases. It is beneficial to know different perspectives of wider audience, encourages a culture of openness, issues are identified, and actions specified. Overall, this facilitates change in practice. We believe, these meetings have had a positive impact due to emphasis on early recognition, implementation of early warning scores in wards, early transfer, and better coordination between the two teams. We work on lines of guidelines published by Clinical Excellence Commission (2020) for the same. Many children with event survival, die before hospital discharge. Early recognition, implementation of trigger tools or warning scores in wards, timely transfer of clinically deteriorating patients, rapid response teams may help improve outcomes. This is a quality improvement audit to see our outcome of cardiac page practices.

Methodology-We are a tertiary cancer hospital in western India. We aim to retrospectively study our electronic medical records of two years (November 2021 to October 2023), pertaining to cardiac page of children (0-18 years) with cancer received by our ICU team. This will be a descriptive review. These do not include cardiac arrest of patients already admitted in the ICU.

Statistical Analysis- In this retrospective cohort study, our objective is to comprehensively analyze the outcomes of in-hospital cardiac arrest in pediatric oncology patients. Through meticulous data collection from medical records, we will capture critical information encompassing patient demographics, oncological disease specifics, cardiac arrest details (including causes), resuscitation interventions, and ultimate outcomes such as survival and neurological status. 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 a form of frequencies and percentages and continuous variables (e.g., age, duration of ICU stay) will be represented as mean and standard deviations.

 
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