| CTRI Number |
CTRI/2025/04/085806 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find if the amount of a certain protein called IRK3 are related to the defense system of the body for being overactive in people with severe lung conditions known as ARDS |
|
Scientific Title of Study
|
To correlate elevated IRAK3 levels and the inflammatory profiles of ARDS patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Govil |
| Designation |
Vice Chairman |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Institute of Critical Care and Anesthesiology Second Floor ICU 10 Medanta The Medicity Sector 38
Gurgaon
HARYANA
122001
India |
| Phone |
09818056688 |
| Fax |
|
| Email |
drdeepak_govil@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnendu Chakraborty |
| Designation |
Principal Scientist |
| Affiliation |
CSIR Institute of Genomics and Integrative Biology IGIB |
| Address |
Department of Cardiorespiratory Disease Biology CSIR Institute of Genomics and Integrative Biology IGIB Mall Road Campus Delhi 110007
New Delhi
DELHI
110007
India |
| Phone |
9051410911 |
| Fax |
|
| Email |
krishnenduind@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Govil |
| Designation |
Vice Chairman |
| Affiliation |
Medanta The Medicity Gurgaon |
| Address |
Institute of Critical Care and Anesthesiology Second Floor ICU 10 Medanta The Medicity Sector 38
Gurgaon
HARYANA
122001
India |
| Phone |
09818056688 |
| Fax |
|
| Email |
drdeepak_govil@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| CSIR Institute of Genomics and Integrative Biology IGIB |
|
|
Primary Sponsor
|
| Name |
CSIR Institute of Genomics and Integrative Biology IGIB |
| Address |
Department of Cardiorespiratory Disease Biology CSIR Institute of Genomics and Integrative Biology IGIB Mall Road Campus Delhi 110007 |
| Type of Sponsor |
Research institution |
|
|
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 Deepak Govil |
Medanta The Medicity |
Institute of Critical Care and Anesthesiology Second Floor ICU 9 ICU 10 ICU 11 and ICU 12 Sector 38 Haryana 122001
Gurgaon
HARYANA |
09818056688
drdeepak_govil@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Committee (MIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J960||Acute respiratory failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged 18 years or older will be included as ARDS primarily affects adults
2 Diagnosis of ARDS Only patients diagnosed with ARDS according to the Berlin criteria with suspected or documented Pneumonia infection in blood sputum and or BAL culture will be included in the study
3 Consent Patients or their legally authorized representatives must provide informed consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Patients receiving corticosteroid treatment
2 Patients with chronic obstructive pulmonary disease asthma ILD Emphysema or IPF
3 Diabetic patients
4 Immunosuppressive Conditions
5 Patients with Platelet count less than 20000 per microlitre and INR less than one and half
6 Patients with lung cancer existing or with history of Tuberculosis
7 Patients who has gone through lung transplant
8 Patients with pulmonary hypertension
9 Patients with Fungal infection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cytokine Profiling and Immune Phenotypes |
The day of Onset of ARDS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Elevated IRAK3 Expression in Immune Suppressive Group |
The day of Onset of ARDS |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
12/05/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Acute Respiratory Distress Syndrome (ARDS) represents a significant cause of morbidity and mortality in critically ill patients.This study will investigate the correlation between cytokine levels (both pro-and anti-inflammatory) in blood and BAL and IRAK3 levels in lung macrophages in ARDS patients. By categorizing patients into sub-phenotypes based on their inflammatory profiles and assessing IRAK3 expression in both alveolar macrophages and peripheral blood monocytes. This study aims to identify potential biomarkers and therapeutic targets for managing ARDS-associated immune suppression and its complications.This study is a cross-sectional, non - interventional investigation conducted on critically ill ARDS patients admitted to the Intensive Care Unit (ICU). 10 ml of blood and 10 ml of BAL sample will be collected from subjects enrolled in the study. Primary outcome of the study is Cytokine Profiling and Immune Phenotypes and Secondary outcome is Elevated IRAK3 Expression in Immune Suppressive Group at the day of onset of ARDS. Future Benefits of the study are establishment of Potential Biomarkers for Infection Risk and Therapeutic Targeting of IRAK3. |