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CTRI Number  CTRI/2022/10/046646 [Registered on: 19/10/2022] Trial Registered Prospectively
Last Modified On: 17/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Observational study 
Study Design  Other 
Public Title of Study   Predicting number of deaths because of sepsis and septic shock In Adult ICU patients  
Scientific Title of Study   Predicting 28-Day mortality in adult patients with sepsis or septic shock using combination of point of care tests including Procalcitonin, Lactate, NT-proBNP, and Diastolic dysfunction: A Prospective Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  FAISAL QURESHI 
Designation  Senior Resident 
Affiliation  AIIMS, Jodhpur 
Address  AICU, 3 Rd Floor EMERGENCY AIIMS JODHPUR

Jodhpur
RAJASTHAN
342008
India 
Phone  08955779326  
Fax    
Email  faisal.qur.90@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pradeep Kumar Bhatia 
Designation  Professor and HOD, Department of Anesthesiology and critical care 
Affiliation  AIIMS, Jodhpur 
Address  AICU 3rd floor Emergency , AIIMS Jodhpur,Rajasthan

Jodhpur
RAJASTHAN
342008
India 
Phone  9829159665  
Fax    
Email  PK_BHATIA@YAHOO.COM  
 
Details of Contact Person
Public Query  
Name  FAISAL QURESHI 
Designation  Senior Resident 
Affiliation  AIIMS, Jodhpur 
Address  AICU, 3rd Floor EMERGENCY AIIMS JODHPUR

Jodhpur
RAJASTHAN
342008
India 
Phone  08955779326  
Fax    
Email  faisal.qur.90@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, JODHPUR 
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  AIIMS JODHPUR ,1ST PHASE BASNI-342005 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Faisal Qureshi  AIIMS JODHPUR ADULT ICU  AICU, 3rd Floor Emergency, Department of Anesthesiology and Critical Care AIIMS, Basni, Jodhpur
Jodhpur
RAJASTHAN 		 08955779326

faisal.qur.90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTE,AIIMS JODHPUR   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Diagnosis of Sepsis or septic shock (Sepsis -3 definition) in patients who are >18 years of age admitted to AICU. 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. Pregnant patients.
3. Pre-existing impaired left ventricular function, myocardial infarction, valvular heart disease, cardiac arrythmias.
4. Traumatic brain injury.
5. Terminal stage of disease (Malignancy, Chronic Renal Failure, End stage liver disease).
6. Poor Echo window
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Predicting the outcome (28-day mortality) using combined score of procalcitonin, lactate, NT-pro BNP, and E/e’ in patients with sepsis and septic shock  biomarker measurement at admission 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing the ability of outcome prediction (28-day mortality) of each of four variable V/s SOFA score.

 		 Biomarker measurement at admission 
Comparing combined score V/s SOFA score for outcome prediction (28-day mortality).
 		 Biomarker measurement at admission 
 
Target Sample Size   Total Sample Size="144"
Sample Size from India="144" 
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)   31/10/2022 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not published yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) -  AT THE PUBLISHING JOURNAL WEBSITE

  6. For how long will this data be available start date provided 21-05-2023 and end date provided 21-01-2070?
    Response - Immediately following publication. No end date.

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

Several point of care biomarkers such as procalcitonin, NT pro BNP, lactate etc. have been independently assessed for their association with outcome in sepsis. Also Diastolic dysfunction was found to be independently, a major predictor of mortality in sepsis. 

Therefore, we are planning a study to predict the short term (28 days) mortality in adult patients with sepsis or septic shock using the combination of easily available point of care tests i.e procalcitonin, lactate, NT-pro BNP, and diastolic dysfunction assessed by transthoracic 2D-Echo.

We hypothesized that a combination of point of care test biomarkers and diastolic dysfunction using E/e’ ratio could predict 28- day mortality in adult patients with sepsis or septic shock with high sensitivity and specificity

 
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