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Clinical Trials/CTRI/2025/09/094403
CTRI/2025/09/094403Not yet recruitingNot Applicable

Evaluation of Procalcitonin and C-Reactive Protein as a prognostic marker among Sepsis patients in Oncology ICU

All India Institute of Medical Sciences New Delhi2 sites in 1 country153 target enrollmentStarted: September 17, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
153
Locations
2
Primary Endpoint
Mortality at Day 28 from the inclusion of study

Study Overview

Brief Summary

Adult patients  admitted in oncology ICU aged > 18 will be screened for sepsis as SOFA score > 2. The Primary objectiveis 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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 69.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Sequential organ failure assessment score more than or equal to 2.

Exclusion Criteria

  • 1.Refusal for participation in the study 2.Autoimmune diseases 3.Postoperative patients (upto postoperative day 3) 3.Recent Myocardial Infection 4.Pregnant patients.

Outcomes

Primary Outcomes

Mortality at Day 28 from the inclusion of study

Time Frame: Mortality at 28 th day from the inclusion of study

Secondary Outcomes

  • 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)

Investigators

Sponsor
All India Institute of Medical Sciences New Delhi
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Subalakshmi

All India Institute of Medical Sciences,New Delhi

Study Sites (2)

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