| CTRI Number |
CTRI/2022/07/044337 [Registered on: 26/07/2022] Trial Registered Prospectively |
| Last Modified On: |
07/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Comparing two biochemical markers prokineticin-2 and procalcitonin for predicting the outcome of infection in patients admitted in ICU |
|
Scientific Title of Study
|
COMPARING THE DIAGNOSTIC AND PROGNOSTIC ACCURACY OF PROKINETICIN-2 AND PROCALCITONIN FOR SEPSIS IN CRITICALLY ILL PATIENTS: A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kavyashree Bhat |
| Designation |
Junior Resident, Department of Anaesthesiology and Critical Care |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, 3rd floor, Emergency block,
Basni Industrial Area, Phase-2
AIIMS, Jodhpur 342001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9480853067 |
| Fax |
|
| Email |
kavyashreebhat7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nikhil Kothari |
| Designation |
Additional Professor, Department of Anaesthesiology and Critical Care |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, 3rd floor, Emergency block,
Basni Industrial Area, Phase-2
AIIMS, Jodhpur 342001
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8003996948 |
| Fax |
|
| Email |
kotharin@aiimsjodhpur.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavyashree Bhat |
| Designation |
Junior Resident, Department of Anaesthesiology and Critical Care |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, 3rd floor, Emergency block,
Basni Industrial Area, Phase-2
AIIMS, Jodhpur 342001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9480853067 |
| Fax |
|
| Email |
kavyashreebhat7@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Jodhpur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
Basni Industrial area
Phase-2
AIIMS Jodhpur
Rajasthan-342001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Kavyashree Bhat |
All India Institute of Medical Sciences, Jodhpur |
Department of Anaesthesiology and Critical Care
3rd floor
Emergency block
Basni Industrial area, Phase-2
Jodhpur
RAJASTHAN |
9480853067
kavyashreebhat7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS JODHPUR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical features suggestive of sepsis as defined by Sepsis-3 definition (2016) at the time of ICU admission |
|
| ExclusionCriteria |
| Details |
Patients/ relatives who refused to give informed consent.
Age less than 18 years.
Patients with terminal stage of disease (malignancy , Acquired immunodeficiency Syndrome, end stage liver or renal disease).
HIV/HBSAG/HCV .
Autoimmune disorders/ metabolic diseases. On long term steroids/ immunosuppressants/ chemotherapy
Osteoarthritis. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare diagnostic and prognostic value of Prokineticin-2 and Procalcitonin in critically ill sepsis patients |
Day 1, Day 7 or on day of discharge or death (whichever is earlier) and on day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Ability of Prokineticin-2 to prognosticate the multi-organ failure in critically ill patients as assessed by SOFA scores.
2) To establish Prokineticin-2 as a predictor of outcome of sepsis in terms of 28 days mortality
3) To compare Prokineticin-2 vs Procalcitonin values as a predictor of outcome of sepsis |
Day 1, Day 7 or on the day of discharge or death (whichever is earlier) and on day 28 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
08/08/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sepsis is a syndrome of physiologic, pathologic, and biochemical abnormalities induced by infection. Early diagnosis and appropriate treatment are key to reduce mortality due to sepsis. Biomarkers play an important role in early diagnosis and prognostication of patients in sepsis.
Patients having clinical features suggestive of sepsis as defined by Sepsis-3 definition (2016) at the time of ICU admission will be enrolled in the study. As a part of routine blood sampling in ICU, whole blood will be taken for the purpose of serum Procalcitonin and Prokineticin-2 estimation on Day 1, Day 7 or on day of discharge or death ( whichever is earlier )and on Day 28. Values of biomarkers will be assessed by ELISA kit method. Diagnostic and Prognostic value of biomarkers will be compared from the values obtained. |