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CTRI Number  CTRI/2025/04/084940 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   SIGNIFICANCE OF IL-6 VALUE IN PATIENTS PRESENTING WITH SYSTEMIC INFLAMMATORY RESPONSE SYNDROME IN PREDICTING OUTCOME - AN OBSERVATIONAL STUDY 
Scientific Title of Study   Prognostic value of IL-6 in SIRS- A Prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B Meenakshi Unnithan 
Designation  DrNB Critical Care Medicine Resident 
Affiliation  PRS HOSPITAL 
Address  Department of Critical care medicine Block 3- Floor 6 Killipalam, Thiruvananthapuram Kerala

Thiruvananthapuram
KERALA
695002
India 
Phone  8547428158  
Fax    
Email  b.meenakshiunnithan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vivek P 
Designation  Senior consultant 
Affiliation  PRS Hospital 
Address  Department of Critical care medicine PRS hospital, Thiruvananthapuram Kerala PIN;695002

Thiruvananthapuram
KERALA
695002
India 
Phone  9496206988  
Fax    
Email  drpvivek@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vivek P 
Designation  Senior consultant 
Affiliation  PRS Hospital 
Address  Department of Critical care medicine PRS hospital, Thiruvananthapuram Kerala PIN;695002

Thiruvananthapuram
KERALA
695002
India 
Phone  9496206988  
Fax    
Email  drpvivek@hotmail.com  
 
Source of Monetary or Material Support  
PRS HOSPITAL, THIRUVANANTHAPURAM 
 
Primary Sponsor  
Name  PRS Hospital 
Address  Killipalam, Thiruvananthapuram Kerala PIN: 695002 
Type of Sponsor  Private hospital/clinic 
 
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 Akhilesh V U  PRS Hospital  Department of Critical care medicine Block 3-6th Floor
Thiruvananthapuram
KERALA 
8547914740

akhilesh530559@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE-PRS HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients admitted to our ICU who gave informed consent for the study meeting
1. SIRS criteria with suspected or confirmed sepsis and /or
2. Presenting in Shock
 
 
ExclusionCriteria 
Details  1. Children less than 18 years of age
2. Patients on long term steroid therapy or immunosuppressive agents
3. Pregnant women
4. Diagnosed cases of congenital or acquired immunodeficiency
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mortality
 
28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of IL-6 values to determine
1.Incidence or onset of organ dysfunction
2.Need for initiation of mechanical ventilation & its duration
3.Initiation of renal replacement therapy with or without hemofeel
4.Need for vasoactive agents or ECMO (Extra Corporeal Membrane Oxygenation)
5. Duration of ICU stay
 
At the time of admission & 48 hourly till date of discharge from ICU 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   23/04/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a single centre prospective observational study regarding prognostic value of Interleukin-6 among patients with systemic inflammatory response syndrome presenting to ICU of a tertiary care centre. 
IL-6 is considered to play an important role as an early indicator of inflammatory response. It is expected that monitoring of such inflammatory parameters would allow to identify the acute moment of the disease and chances of further clinical worsening.
In our study, all study patients will undergo standard treatment according to the discretion of treating physician and study related data will be collected in case record form. Close monitoring of clinical course along with laboratory parameters including biomarkers( Interleukin -6, Procalcitonin, C- reactive protein) will be done till date of discharge from ICU. Detailed analysis will be performed regarding biomarker values with 28 day mortality along with comparison of IL6 value with incidence or onset of organ dysfunction, need for mechanical ventilation and its duration, need for renal replacement therapy with or without cytokine filter, need for vasoactive agents or ECMO, duration of ICU stay.
With increasing mortality rates in patients with hyper inflammatory states including septic shock, if role of IL-6 in prognostication can be shown it could pave path for early therapy targeted at reducing inflammatory markers which could in turn help in reducing morbidity as well as mortality.
 
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