| CTRI Number |
CTRI/2025/12/099784 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
A study to look at Health and Recovery of Cancer Patients in the Intensive Care Unit |
|
Scientific Title of Study
|
Epidemiology and outcomes of Oncology patients admitted in the ICU |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 901232_Version 1.1 dated 06.11.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpushp Bhosale |
| Designation |
Professor and head, Division of Critical Care Medicine |
| Affiliation |
ACTREC TMC |
| Address |
Department of Anesthesia, Critical Care and Pain,
7th floor, RRS Building, ACTREC, Tata Memorial Centre,
Kharghar, Navi Mumbai, 410210
Mumbai MAHARASHTRA 410210 India |
| Phone |
9619310657 |
| Fax |
|
| Email |
shilbhosale@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shilpushp Bhosale |
| Designation |
Professor and head, Division of Critical Care Medicine |
| Affiliation |
ACTREC TMC |
| Address |
Department of Anesthesia, Critical Care and Pain,
7th floor, RRS Building, ACTREC, Tata Memorial Centre,
Kharghar, Navi Mumbai, 410210
Mumbai MAHARASHTRA 410210 India |
| Phone |
9619310657 |
| Fax |
|
| Email |
shilbhosale@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shilpushp Bhosale |
| Designation |
Professor and head, Division of Critical Care Medicine |
| Affiliation |
ACTREC TMC |
| Address |
Department of Anesthesia, Critical Care and Pain,
7th floor, RRS Building, ACTREC, Tata Memorial Centre,
Kharghar, Navi Mumbai, 410210
Mumbai MAHARASHTRA 410210 India |
| Phone |
9619310657 |
| Fax |
|
| Email |
shilbhosale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, Critical care and Pain, OT complex, Seventh floor, RRS Building, ACTREC, Navi Mumbai - 410210 India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Department of Anaesthesia Critical Care and Pain, ACTREC, Navi Mumbai - 410210 |
| 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 Shilpushp Bhosale |
Tata Memorial Centre |
Department of Anaesthesia Critical Care and Pain, ACTREC, Kharghar, Navi Mumbai - 410210 Mumbai MAHARASHTRA |
9619310657
shilbhosale@gmail.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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients admitted in the ICU |
|
| ExclusionCriteria |
| Details |
Patients less than 18 yrs of age and Post BMT patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ICU mortality |
At ICU discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hospital Mortality
2. Risk factors that predict mortality on multivariate analysis
|
At ICU discharge |
|
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
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)
|
05/01/2026 |
| 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
|
With significant development of treatment of cancer patients, survival and prognosis have been continually improving both for solid and haematological malignancies. Since cancer and treatment related complications are common many patients may need admission to the ICU for managing infectious complications, respiratory failure, septic shock etc. Because of this, requirements for ICU services access and use will continue to increase. It is important to identify patients who are at risk of developing these complications and who will benefit from icu care. Several prognostic factors including the need for vasopressors and invasive mechanical ventilation have been proposed however, their use in clinical practice is limited because of their lack of external validation and limited predictive power. Early admission to the ICU has been shown to improve survival. The ICU mortality rate in cancer patients is variable and can range between 30 percent and 77 percent. This wide range of mortality rates is due to the multiple factors that may affect outcome in these patients, such as malignancy type, cause of admission, presence of metastasis, number of organ failures, and therapies before ICU admission. We planned to study the characteristics of patients admitted to the ICU and risk factors associated with poor outcomes. |