Evaluation of Diagnostic Accuracy of Novel biomarker Presepsin compared to Procalcitonin in patients with Suspected Sepsis coming to Emergency Department

Materials and Methods:

a) Study Design : A Cross Sectional Comparative Observational Study in which different blood samples will be tested.

b) Study Duration : 18 months

c) Sampling technique: Purposive Sampling

Sample size is estimated considering prevalence of sepsis patient presenting to Emergency is taken as 6.4%(ref).Sample size when calculated comes to 92.

In patients presenting to Emergency Department with suspected sepsis; blood samples are drawn for blood culture and sensitivity and serum procalcitonin levels routinely. Along with these, blood samples will be drawn for Presepsin testing. After 48 hours blood culture reports will be collected ,along with Procalcitonin and Presepsin levels .These values will be compared with blood culture reports.

d) Study Population and source of data

Patients presenting above 18 years with suspected sepsis presenting to Emergency Department based on

1)  Clinician’s suspicion of sepsis

2. A known sepsis

3. Signs and symptoms suggestive of sepsis

4. High risk of infection

e) Subject Eligibility

1. Inclusion Criteria

-   Age> 18 years

-  Patients with suspected sepsis presenting to Emergency Department based on

*  Clinician’s suspicion of sepsis

* A known focus of sepsis

* Signs and symptoms suggestive of sepsis

* High risk of sepsis

2. Exclusion Criteria

* Immunocompromised

* Malignancy

f) Study Assessment of end points

Patients will be tracked to record reports of Presepsin ,Procalcitonin and after 48 hours blood culture report.

g) Study Conduct

The study will be conducted in the Emergency Department of JSS Hospital, Mysuru in patients aged above 18 years presenting with suspected sepsis to Emergency Department.

1)  Data of patients admitted at Emergency Department of JSS hospital fulfilling and exclusion criteria will be collected

2. Patients with sepsis will be selected based on clinician’s suspicion of sepsis. Blood samples will be collected from patients and will be sent to Microbiology lab.

3. Samples will be stored at Microbiology lab and then will be analyzed by ELISA with respective biomarker kits.

h) Instruments required : Presepsin and Procalcitonin test kits

i) Informed Consent: English and Kannada forms are included

j)  Investigational Product Management

Presepsin test kit will be collected and stored in Microbiology Laboratory in JSS Hospital, Mysuru. It will be stored at 2-8o C. .Presepsin samples will be collected and stored Test will be run in batches whenever sufficient samples are available. The Primary Investigator will bear all the cost of the Biomarker and the burden will not fall on the patient.

k) Summary statistics will be done by means of proportions for categorical/binary variables and mean, median, standard deviation , Inter Quartile Range (IQR) for continuous variables. Inferential statistics will be done by using independent t test ,chi square test, ROC curve with AUC, sensitivity , specificity, PPV, NPV with 95% CI and binary logistic regression. All the statistical methods will be done using SPSS 28.0 version of windows . P < 0.05 will be considered statistically significant.