| CTRI Number |
CTRI/2026/03/105713 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Ambispective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of different inflammation responses and their effect on illness severity and survival in patients with acute respiratory distress syndrome |
|
Scientific Title of Study
|
Inflammatory Phenotypes in Acute Respiratory Distress Syndrome Incidence and Association with Morbidity and Mortality |
| 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 Kapil Zirpe |
| Designation |
HOD and Director Neuro Trauma Unit |
| Affiliation |
Grant Medical Foundation Ruby Hall Clinic |
| Address |
Grant Medical Foundation Ruby Hall Clinic
40 Sassoon Road Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9822844212 |
| Fax |
02066455628 |
| Email |
kapilzirpe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kaustubh Zirpe |
| Designation |
DrNB SS Critical Care Medicine |
| Affiliation |
Grant Medical Foundation Ruby Hall Clinic |
| Address |
Grant Medical Foundation Ruby Hall Clinic
40 Sassoon Road Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
8983380750 |
| Fax |
02066455628 |
| Email |
drkaustubhzirpe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaustubh Zirpe |
| Designation |
DrNB SS Critical Care Medicine |
| Affiliation |
Grant Medical Foundation Ruby Hall Clinic |
| Address |
Grant Medical Foundation Ruby Hall Clinic
40 Sassoon Road Pune
MAHARASHTRA
411001
India |
| Phone |
8983380750 |
| Fax |
02066455628 |
| Email |
drkaustubhzirpe@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Grant Medical Foundation Ruby Hall Clinic |
| Address |
40 Sassoon Road Pune 411001 |
| Type of Sponsor |
Other [Trust Hospital] |
|
|
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 Kaustubh Zirpe |
Grant Medical Foundation Ruby Hall Clinic |
40 Sassoon Road Pune 411001
Pune
MAHARASHTRA |
8983380570
02066455628
drkaustubhzirpe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Poona Medical Research Foundation Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
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 |
1 Patients with ARDS
2 Patients within 7 days from invasion or exacerbation of respiratory symptoms or acute onset of ARDS
3 Patients with bilateral opacities not fully explained by effusions
4 Patients with respiratory failure not fully explained by cardiac failure
5 PF ratio less than 300mmHg with PEEP at least 5cm H2O
6 ARDA diagnosis within 48 hours |
|
| ExclusionCriteria |
| Details |
1 Patients with congestive cardiac failure
2 Patients with liver failure
3 Patients with chronic renal failure requiring renal dialysis therapy
4 Patients with burns more than 20 percent of total body surface area
5 Patients with chronic inflammatory or autoimmune disease
6 Pregnant or lactating women
7 Patients with palliative care |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hyper inflammatory and hypo inflammatory phenotypes among ARDS patients admitted to ICU |
Number of ventilator free days within 28 days of ICU admission between the phenotypes
Duration of ICU stay in days across the phenotype groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ICU mortality in hyper inflammatory verses hypo inflammatory |
Within 28days from ICU admission |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
20/03/2026 |
| 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="2"
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
|
Rationale of the study
Understanding the incidence of inflammatory
phenotypes in ARDS patients and their association with clinical outcomes could
Improve risk
stratification by identifying patients at higher risk
of mortality or complications.
Guide targeted therapies
tailored to the patients inflammatory profile potentially optimizing treatment
efficacy.
Provide insights into pathophysiology
and aid future research on personalized management strategies for ARDS.
Limited data exist on their prevalence and impact in
Indian ICUs making this study essential.
|