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CTRI Number  CTRI/2021/06/034301 [Registered on: 18/06/2021] Trial Registered Prospectively
Last Modified On: 25/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Prospective Observational Study of retrospective collected data 
Study Design  Other 
Public Title of Study   To study the characteristics and outcomes of cancer patients with coronavirus (Covid 19) admitted to the intensive care unit in a Cancer Centre 
Scientific Title of Study   To evaluate the characteristics and outcomes of cancer patients with coronavirus (Covid 19) admitted to the intensive care unit in a Tertiary Cancer Centre and identify risk factors that predict outcomes 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
900807_Protocol Version 2.0 dated 04.06.2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr J V Divatia  
Designation  Professor and Head 
Affiliation  Tata Memorial Centre 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  02224177041  
Fax    
Email  jdivatia@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr J V Divatia  
Designation  Professor and Head 
Affiliation  Tata Memorial Centre 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  02224177041  
Fax    
Email  jdivatia@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr J V Divatia  
Designation  Professor and Head 
Affiliation  Tata Memorial Centre 
Address  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  02224177041  
Fax    
Email  jdivatia@yahoo.com  
 
Source of Monetary or Material Support  
Dept. of Anaesthesia, Critical Care and Pain, 2nd Floor Main Building, Tata Memorial Hospital, Dr Ernest Borges Road, Parel, Mumbai, Maharashtra 400012  
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr. E Borges Road Parel, Mumbai Pin 400012 
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 J V Divatia  Tata Memorial Hospital  Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai
Mumbai
MAHARASHTRA 
02224177041

jdivatia@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All adult patients >18 years diagnosed with Covid-19 admitted to the Intensive Care unit in TMH  
 
ExclusionCriteria 
Details  Post Bone Marrow transplant  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality in the ICU for cancer patients with covid-19  At 30 day 
 
Secondary Outcome  
Outcome  TimePoints 
In-hospital mortality and 30-day mortality for cancer patients with covid-19  At 30 day
 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/06/2021 
Date of Study Completion (India) 10/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/08/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Background

The coronavirus disease 2019 (COVID‐19) pandemic has kept the world at ransom and led to unprecedented fears and stress. It has led to severe pressure on the intensive care resources bringing out innovative means to manage the high demand for intensive care services.(1) The spectrum of COVID-19 spans from asymptomatic through moderate to severe. About 5% of all patients and 20% of hospitalized patients with COVID-19 may experience severe manifestations necessitating intensive care unit (ICU) admission.(2) Mortality of COVID-19 patients admitted in the ICU is high. In one meta-analysis,(3) 31 % of patients admitted to the ICU died, while in another, mortality ranged from 0-84.6%, with a pooled mortality of 41.6%.(4)

 

Cancer patients may be at increased risk of complications and mortality from COVID-19 owing to the systemic effects of malignancy, immune suppression after chemotherapy, treatment-related cardiovascular, renal and pulmonary toxicities, as well as the co-existence of co-morbidities. Active cancer is associated with increased odds of death among patients with COVID-19.(5) In two large series of cancer patients with COVID-19, mortality ranged from 13-28%.(6,7)6,7 In a meta-analysis of 32 studies, all-cause mortality as well as the need for ICU admission were higher in COVID-19 patients with cancer than those without cancer.(8)11

However data of cancer patients admitted to the ICU with Covid-19 related complications is scarce, possibly due to restriction admission of cancer patients to the ICU in the setting of a pandemic. TMH ICU has been admitting cancer patients with Covid-19 throughout this pandemic. We are uniquely placed to generate data on outcomes of cancer patients with Covid-19 admitted to the ICU, and to determine which patient groups and risk factors are most associated with mortality. We therefore plan to do a retrospective review of the cancer patients admitted to the TMH with Covid-19.

 

Aims and objective

1) To evaluate the characteristics and outcomes of cancer patients with coronavirus in the Intensive Care Unit 

2) To identify risk factors that might predict poor outcomes

 

Study design and Methods

We will do a retrospective and prospective chart review of all the patients with Covid-19 admitted to the ICU from the over period from 1st January 2020 to 31st December 2021 after taking approval from the ethics committee. We will start the prospective data collection from the date of approval of protocol amendment Version 2.0. We will record all the data such as demographics, primary diagnosis, type of cancer, status of disease, indication for ICU admission, APACHE II Score, SOFA score, length of stay in ICU, duration & type of ventilation, treatments and interventions offered, ICU outcome, hospital outcome and outcome at 30 days after ICU admission.

Primary outcome will be mortality in the ICU for cancer patients with covid-19.

Secondary outcomes would be in-hospital mortality and 30-day mortality for cancer patients with covid-19.

In patients with cancer and Covid-19, we will try to identify significant predictors of mortality such as type of cancers (haematological versus solid tumours), operative versus non-operative admission, high-flow nasal oxygen, mechanical ventilation, severity of illness, vasopressors etc.

Since there have been admissions of staff and relatives of staff and patients who had covid-19 but did not have cancer, we will attempt to determine mortality in the cancer versus non-cancer patients with covid-19 in the ICU.

 

Inclusion criteria

All adult patients >18 years diagnosed with Covid-19 admitted to the Intensive Care unit in TMH

Exclusion criteria

Post Bone Marrow transplant

 

Statistical Analysis

Data will be analyzed using SPSS-20 software. Continuous variables will be compared using either Student’s t-test or Mann-Whitney U test depending on whether the data is normally distributed or not.

Categorical data will be analyzed by either Pearson’s chi square or Fisher’s exact test.

A p value of <0.05 will be considered significant.

Univariable and Multivariable regression analysis will be performed to determine factors significantly associated with ICU mortality in patients with cancer and Covid-19.

 
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