| CTRI Number |
CTRI/2025/09/094403 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate if Procalcitonin and C- reactive protein can be used to predict mortality in sepsis patients with Cancer. |
|
Scientific Title of Study
|
Evaluation of Procalcitonin and C-Reactive Protein as a prognostic marker among Sepsis patients in Oncology ICU |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subalakshmi |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences,New Delhi |
| Address |
329, masjid moth road, south ex part 2, New Delhi
Department of Onco Anaesthesia
Dr.B.R.Ambedkar Institute Rotary Cancer Institute,
AIIMS,New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9585743398 |
| Fax |
|
| Email |
subalakshmi72@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shweta Bhopale |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Department of Onco anaesthsesia and Palliative Medicine,
DR.B.R.A.I.R.C.H
AIIMS,
Ansari Nagar East,
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8178188976 |
| Fax |
|
| Email |
dr.shwetabhopale06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Shweta Bhopale |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
Department of Onco anaesthesia and Palliative Medicine,
DR.B.R.A.I.R.C.H
AIIMS,
Ansari Nagar East,
New Delhi
New Delhi
DELHI
110029
India |
| Phone |
8178188976 |
| Fax |
|
| Email |
dr.shwetabhopale06@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES,NEW DELHI,INDIA,PINCODE:110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar East,New Delhi,India.
PINCODE-110029. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRSUBALAKSHMI |
Dr.B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS New Delhi |
Department of Onco anaesthesia,Dr B.R.Ambedkar Institute Rotary Cancer Hospital, Ansari Nagar East, AIIMS Campus, New Delhi,India,pincode-110029
New Delhi
DELHI |
9585743398
subalakshmi72@gmail.com |
| DRSUBALAKSHMI |
National Cancer Institute-AIIMS,Jhajjar. |
Department of Onco anaesthesia, National Cancer Institute, AIIMS Jhajjar,Badsa,Haryana,India PINCODE- 124105
Jhajjar
HARYANA |
9585743398
subalakshmi72@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
Sequential organ failure assessment score more than or equal to 2 |
|
| ExclusionCriteria |
| Details |
1.Refusal for participation in the study
2.Autoimmune diseases
3.Postoperative patients (upto postoperative day 3)
3.Recent Myocardial Infection
4.Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality at Day 28 from the inclusion of study |
Mortality at 28 th day from the inclusion of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of ICU stay from the day of inclusion in the study to discharge/death
SOFA score at Day 0 ,2 & 4 from the day of inclusion in the study |
During the course of ICU stay |
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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)
|
17/09/2025 |
| 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="1"
Months="6"
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
|
Adult patients admitted in oncology ICU aged > 18 will be screened for sepsis as SOFA score > 2. The Primary objective is to evaluate PCT and CRP as a marker in predicting mortality among sepsis patients in oncology ICU ; our Secondary objective is to assess the correlation of PCT and CRP with SOFA score in predicting severity of disease. and to assess the correlation of PCT and CRP with length of ICU stay. PCT, CRP will be measured on Day 0, 2 and 4. Patients will be followed up for a mortality, duration of ICU stay and recovery. At 28 th day patient/ patient’s attender will be called telephonically to assess for mortality or recovery. The discriminant performance of Day 0, 2, and 4 values of CRP and PCT in predicting within 28-day mortality will be assessed using the ROC curve analysis. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) will be calculated. |