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
|
|
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
|
|
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 (COVIDâ€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. |