1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sreekaravr@gmail.com].
   


6. For how long will this data be available start date provided 01-12-2026 and end date provided 01-12-2031?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Patients presenting to the Emergency department with clinically suspected infection will undergo routine clinical workup. After workup patients with undifferentiated sepsis will be screened for our study. Initial workup by the treating physician includes stabilization of patient , history taking, clinical examination. 

Undifferentiated sepsis is defined as a septic patient with no obvious infection source identified by history and clinical examination by a treating physician. After obtaining consent, point of care ultrasound protocol will be performed by the investigator as mentioned below.

Consent will be obtained from the patient or legally accepted representative, re consent will be from the patient in the due course if he is able to provide.

The point of care ultrasound protocol is performed routinely as a part of acute management of sick patients in our emergency department. As the study is performed bedside by investigator independently, it will not alter the ongoing resuscitation or delay patient care.

The point of care ultrasound will be carried out by the investigator as briefed in the methodology. The diagnostic ultrasound protocol will be completed in less than 10 minutes duration and will be performed along with patient management. It is ensured that the study procedure will not affect the ongoing patient care.

The final diagnosis obtained by the admitting department will be regarded as the gold standard and will be obtained after reviewing the medical records of the patients for a maximum period of 7 days. It includes all imaging and laboratory data during that hospital stay.

The patient who expire after recruitment and before arriving at the final diagnosis will be excluded from the study.

The consent is taken from the legally accepted representative, if the patient is too sick to give consent,  consent is taken again from the patient in the due course of time as the patient improves.

Point of care ultrasound protocol

Point of care ultrasound protocol is done using GE healthcare portable machine bedside, it consists of 3 probes 

-a cardiac probe - GE 3SC-RS sector array probe with frequency 1-4 MHz

-a linear probe - GE L4-12t-RS wideband linear array probe with frequency 4.2-13MHz

-a convex probe - GE C1-5-RS wideband convex array probe with frequency 1.5-5.0 MHz

Point of care ultrasound is performed by the investigator once the primary treating physician after clinical examination and history concluded the patient as undifferentiated sepsis patient. Point of care ultrasound is performed at all the below mentioned anatomical sites. Point of care ultrasound is performed by the investigator according to the book Ma & Mateer’s Emergency Ultrasound 3 rd edition by O.John Ma, according to the protocol. The competency of the investigator will be assessed by performing at least a minimum of 50 scans before the start of the study.

The source of sepsis is further classified as respiratory, abdominal, urosepsis, musculoskeletal and others

The protocol has been named Sepsis ultrasound protocol to identify source etiology rapidly (SUPER protocol)