| 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
|
|
|
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
|
|
|
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. |