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CTRI Number  CTRI/2021/02/031517 [Registered on: 24/02/2021] Trial Registered Prospectively
Last Modified On: 25/02/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Observational study on undergoing surgery patients  
Scientific Title of Study   Observational study to assess inflammatory biomarker profile in Patients undergoing surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prashanth Varkey 
Designation  Director 
Affiliation  Zum Heilen Diagnostic and Therapeutics  
Address  Zum Heilen Diagnostic and Therapeutics , No 143, Bethel LaneThrissur

Thrissur
KERALA
680001
India 
Phone  9249584682  
Fax    
Email  drpvarkey@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prashanth Varkey 
Designation  Director 
Affiliation  Zum Heilen Diagnostic and Therapeutics  
Address  Zum Heilen Diagnostic and Therapeutics , No 143, Bethel LaneThrissur


KERALA
680001
India 
Phone  9249584682  
Fax    
Email  drpvarkey@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prashanth Varkey 
Designation  Director 
Affiliation  Zum Heilen Diagnostic and Therapeutics  
Address  Zum Heilen Diagnostic and Therapeutics , No 143, Bethel LaneThrissur


KERALA
680001
India 
Phone  9249584682  
Fax    
Email  drpvarkey@gmail.com  
 
Source of Monetary or Material Support  
Zum Heilen Diagnostic & Therapeutics (ZH D&T), No 143, Bethel Lane Thrissur 
 
Primary Sponsor  
Name  Zum Heilen Diagnostic Therapeutics ZH DT 
Address  No 143, Bethel Lane Thrissur 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Pradeoth KM  Jubilee MissionMedical Collegeand ResearchInstitute(JMMCRI),  Jubilee Mission MedicalCollege and ResearchInstitute (JMMCRI),Department of plastic surgery Roomno 2 1st floor Thrissur,Kerala India - 680005 Thrissur KERALA
Thrissur
KERALA 		 04872432200

pradeoth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe-Jubilee Mission Medical College and Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:T07||Unspecified multiple injuries. Ayurveda Condition: Y81,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age group 19 – 70 yrs
2.Both male and females involved
3.Patients who underwent major and minor surgical procedures along with diabetic foot, necrotizing fasciitis, abdominal sepsis will be included in the study
4.Subjects who are willing to provide written consent for the study
5.Subject willing to abide by and comply with the study protocol
 
 
ExclusionCriteria 
Details  1.Patients above 70yrs old
2.Pregnancy and lactation
3.Other health conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To assess and correlate the pattern of IL-6, TNF-α, IFN-γ, MIP1α, MIP1β, MCP1, IP-10, IL-1β during the post-operative septic conditions from baseline to end of study  Day 0,Day 3and Day 5 
 
Secondary Outcome  
Outcome  TimePoints 
1.To identify the pattern of expression of inflammatory markers during the prognosis of the septic conditions  Day 0,Day 3and Day 5 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   26/02/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Unchecked sepsis in patients during post-surgical conditions has become a major risk factor for mortality. In a study conducted in an Indian tertiary hospital, it was observed that ICU mortality, hospital mortality, and 28-day mortality were 56%, 63.6%, and 62.8%, respectively (Chatterjee et al., 2017). This further shows the how critical is the requirement for detection and monitoring of sepsis in patients who underwent surgical procedures. In order to regulate the mortality rates caused by surgical sepsis, new approaches which could be precise, faster and cost effective must have to be inculcated in the field of medical health care. So, the early detection of sepsis by assessment of inflammatory markers in blood samples from patients with post-surgical conditions via RT-PCR has been proposed in this study. 3ml peripheral vein blood will be collected with EDTAK2 anticoagulant; serum and plasma will be separated.1.5ml of saliva will be collected using saliva collector. All types of samples will be collected on day 0, day 3 and day 5. IL-6, TNF-α, IFN-γ, MIP1α, MIP1β, MCP1, IP-10, IL-1β will be the inflammatory markers that will be assessed by RT-PCR. 
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