| CTRI Number |
CTRI/2025/08/092798 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Does admission to a cancer specialized ICU favorably impact treatment outcomes for critically ill cancer patients; a retrospective analysis of prospective database |
|
Scientific Title of Study
|
Comparative Outcomes of Critically Ill Cancer Patients in Specialized Cancer ICUs Versus General ICUs: A Retrospective Database Analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raymond Dominic Savio |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Proton Cancer Centre |
| Address |
Department of Critical Care Services, 2nd floor, Apollo Proton Cancer Centre,
4/661, Dr Vikram Sarabai Instronic Estate 7th st, Dr. Vasi Estate, Phase II, Tharamani, Chennai
Chennai
TAMIL NADU
600041
India |
| Phone |
8056051847 |
| Fax |
|
| Email |
raymond.savio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raymond Dominic Savio |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Proton Cancer Centre |
| Address |
Department of Critical Care Services, 2nd floor, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th st, Dr. Vasi Estate, Phase II, Tharamani, Chennai
Chennai
TAMIL NADU
600041
India |
| Phone |
8056051847 |
| Fax |
|
| Email |
raymond.savio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raymond Dominic Savio |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Proton Cancer Centre |
| Address |
Department of Critical Care Services, 2nd floor, Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate 7th st, Dr. Vasi Estate, Phase II, Tharamani, Chennai
Chennai
TAMIL NADU
600041
India |
| Phone |
8056051847 |
| Fax |
|
| Email |
raymond.savio@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Raymond Dominic Savio |
| Address |
Apollo Proton Cancer Centre, 4/661, Dr Vikram Sarabai Instronic Estate,Phase II, Tharamani, Chennai 600041, Tamil Nadu, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Raymond Dominic Savio |
Apollo Proton Cancer Centre |
Department of Critical Care Services, 2nd floor, 4/661, Dr Vikram Sarabai Instronic Estate 7th St, Dr. Vasi Estate, Phase II, Tharamani, Chennai, Tamil Nadu 600041
Chennai
TAMIL NADU |
8056051847
raymond.savio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Bio Medical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D49||Neoplasms of unspecified behavior, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Admission of critically ill cancer patients to General ICUs |
Clinical outcomes like Mortality, ICU & Hospital LOS, Requirement of organ support, Nosocomial infection rates in critically ill cancer patients in General ICUs |
| Intervention |
Admission of critically ill cancer patients to Specialized Cancer ICUs |
Clinical outcomes like Mortality, ICU & Hospital LOS, Requirement of organ support, Nosocomial infection rates in critically ill cancer patients in Specialized Cancer ICUs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Admission to either a Specialized Cancer ICU or a General ICU |
|
| ExclusionCriteria |
| Details |
Patients with incomplete medical records
Patients admitted for end-of-life care |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare mortality rates of critically ill cancer patients admitted to cancer-specialized ICUs and general ICUs. |
4-8 weeks after admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess differences in ICU length of stay (LOS), ICU readmission rate and hospital LOS.
To evaluate the use of organ support interventions (mechanical ventilation, vasopressors, renal replacement therapy) between the two groups.
To study the rates of nosocomial infections (VAP, CLABSI, CAUTI, SSI) between these two groups
To identify factors associated with improved outcomes in cancer-specialized ICUs. |
Retrospective analysis |
|
|
Target Sample Size
|
Total Sample Size="750"
Sample Size from India="750"
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)
|
01/09/2025 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Critically ill cancer patients often require ICU care due to disease progression, treatment complications, or infections. Specialized cancer ICUs aim to provide focused, multidisciplinary care, but whether they improve outcomes over general ICUs remains unclear. This retrospective study will compare in-hospital mortality, ICU/hospital length of stay, ICU readmissions, use of organ support (mechanical ventilation, vasopressors, RRT), and rates of ICU-acquired infections (VAP, CLABSI, CAUTI, SSI) between cancer-specialized and general ICUs.
Hypothesis: Admission to a cancer-specialized ICU is associated with improved survival and better clinical outcomes than general ICU admission. |