To study the characteristics and outcomes of cancer patients with coronavirus (Covid 19) admitted to the intensive care unit in a Cancer Centre
- Conditions
- Neoplasms, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,
- Registration Number
- CTRI/2021/06/034301
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
**Background**
The coronavirusdisease 2019 (COVIDâ€19) pandemic has kept the world at ransom and led tounprecedented fears and stress. It has led to severe pressure on the intensivecare resources bringing out innovative means to manage the high demand for intensivecare services.(1) The spectrum of COVID-19 spans from asymptomaticthrough moderate to severe. About 5% of all patients and 20% of hospitalizedpatients with COVID-19 may experience severe manifestations necessitatingintensive care unit (ICU) admission.(2) Mortality of COVID-19 patients admittedin the ICU is high. In one meta-analysis,(3) 31 % of patientsadmitted to the ICU died, while in another, mortality ranged from 0-84.6%,with a pooled mortality of 41.6%.(4)
Cancerpatients may be at increased risk of complications and mortalityfrom COVID-19 owing to the systemic effects of malignancy, immune suppressionafter chemotherapy, treatment-related cardiovascular, renal and pulmonarytoxicities, as well as the co-existence of co-morbidities. Active cancer isassociated with increased odds of death among patients with COVID-19.(5) In twolarge series of cancer patients with COVID-19, mortality ranged from13-28%.(6,7)6,7In a meta-analysis of 32 studies, all-cause mortality as well as the need for ICU admission werehigher in COVID-19 patients with cancer than those without cancer.(8)11
However data of cancer patients admitted to theICU with Covid-19 related complications is scarce, possibly due to restrictionadmission of cancer patients to the ICU in the setting of a pandemic. TMH ICUhas been admitting cancer patients with Covid-19 throughout this pandemic. Weare uniquely placed to generate data on outcomes of cancer patients withCovid-19 admitted to the ICU, and to determine which patient groups and riskfactors are most associated with mortality. We therefore plan to do aretrospective review of the cancer patients admitted to the TMH with Covid-19.
**Aimsand objective**
1) To evaluate the characteristics and outcomes of cancerpatients 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 thepatients with Covid-19 admitted to the ICU from the over period from 1st January 2020 to 31stDecember 2021 after taking approval from the ethics committee. We will start the prospectivedata collection from the date of approval of protocol amendment Version 2.0.We will record all thedata such as demographics, primarydiagnosis, type of cancer, status of disease, indication for ICU admission, APACHEII Score, SOFA score, length of stay in ICU, duration & type ofventilation, treatments and interventions offered, ICU outcome, hospitaloutcome and outcome at 30 days after ICU admission.
**Primary outcome** will be mortality in the ICUfor cancer patients with covid-19.
**Secondary outcomes** would be in-hospital mortality and 30-day mortality forcancer patients with covid-19.
In patients with cancer and Covid-19, we will tryto identify significant predictors of mortality such as type of cancers(haematological versus solid tumours), operative versus non-operativeadmission, high-flow nasal oxygen, mechanical ventilation, severity of illness,vasopressors etc.
Since there have been admissions of staff andrelatives of staff and patients who had covid-19 but did not have cancer, wewill attempt to determine mortality in the cancer versus non-cancer patientswith covid-19 in the ICU.
**Inclusion criteria**
Alladult patients >18 years diagnosed with Covid-19 admitted to the IntensiveCare unit in TMH
**Exclusion criteria**
PostBone Marrow transplant
**Statistical Analysis**
Datawill be analyzed using SPSS-20 software. Continuous variables will be comparedusing either Student’s t-test or Mann-Whitney U test depending on whether thedata is normally distributed or not.
Categoricaldata will be analyzed by either Pearson’s chi square or Fisher’s exact test.
Ap value of <0.05 will be considered significant.
Univariableand Multivariable regression analysis will be performed to determine factorssignificantly associated with ICU mortality in patients with cancer andCovid-19.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 500
All adult patients >18 years diagnosed with Covid-19 admitted to the Intensive Care unit in TMH.
Post Bone Marrow transplant.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mortality in the ICU for cancer patients with covid-19 At 30 day
- Secondary Outcome Measures
Name Time Method In-hospital mortality and 30-day mortality for cancer patients with covid-19 At 30 day
Trial Locations
- Locations (1)
Tata Memorial Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Tata Memorial Hospital🇮🇳Mumbai, MAHARASHTRA, IndiaDr J V DivatiaPrincipal investigator02224177041jdivatia@yahoo.com