| 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
|
|
|
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
|
|
|
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. |