| CTRI Number |
CTRI/2025/07/090794 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of body signals and bedside scan to track recovery in severe lung failure |
|
Scientific Title of Study
|
Utility of untargeted metabolomics and point of care ultrasound for the prediction
of outcomes in ARDS (acute respiratory distress syndrome) patients- A prospective cohort 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 |
Ms Ashritha A Udupa |
| Designation |
PhD Scholar |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Critical Care Medicine, Kasturba Medical College, Manipal, Trauma and Emergency block, First floor
Udupi
KARNATAKA
576104
India |
| Phone |
9110231426 |
| Fax |
|
| Email |
ashrithaaudupa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Souvik Chaudhuri |
| Designation |
Professor and Guide |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Critical Care Medicine, Kasturba Medical College, Manipal, Trauma and Emergency block, First floor
Udupi
KARNATAKA
576104
India |
| Phone |
9937178620 |
| Fax |
|
| Email |
souvik.chaudhuri@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Souvik Chaudhuri |
| Designation |
Professor and Guide |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Critical Care Medicine, Kasturba Medical College, Manipal, Trauma and Emergency block, First floor
Udupi
KARNATAKA
576104
India |
| Phone |
9937178620 |
| Fax |
|
| Email |
souvik.chaudhuri@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR),V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Ms Ashritha A Udupa |
| Address |
Department of Critical Care Medicine, Kasturba Medical College, Manipal, MAHE, Manipal, Karnataka 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Souvik Chaudhuri |
Kasturba Hospital Manipal |
Department of Critical Care Medicine, Trauma and Emergency block, First floor, Kasturba Medical College, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9937178620
souvik.chaudhuri@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J80||Acute respiratory distress syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
The study will include adult ARDS patients aged 18-80 years of either gender. ARDS should be diagnosed based on the new global definition of ARDS. |
|
| ExclusionCriteria |
| Details |
Patients of ARDS on Invasive mechanical ventilation (IMV) greater than 48 hours will be excluded. Patients with lung trauma, chest wall deformities where lung ultrasound may be unreliable will also be excluded. ARDS patients with immunosuppression as defined by a course of corticosteroids lasting more
than two weeks at doses exceeding 20 mg of prednisolone per day, will be excluded. Patients with a history of solid organ or bone marrow transplantation, who have been treated
with chemotherapy for any type of malignancy, any biological agent, prednisone equivalent of more than 10mg per day and 700 mg cumulative dose, antiproliferative agents and B cell or T cell
depletion medications, will be excluded. Also, Pregnant patients with ARDS will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality at 28 days from ARDS diagnosis. |
28 days from ARDS diagnosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prolonged Length of stay in ICU (greater than 14 days). To identify specific metabolites to reliably predict 28 day mortality in ARDS patients at an early stage of ARDS. Identification of metabolites to predict higher Driving pressure greater than or equal to 16 cm H2O in ARDS patients & also to identify sub phenotype 2 of ARDS. |
At Baseline, 2 weeks & 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
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)
|
01/08/2025 |
| 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="3"
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 prospective cohort study aims to evaluate whether certain naturally occurring chemical compounds in the blood (called metabolites) and findings from bedside lung ultrasound can predict outcomes in patients with Acute Respiratory Distress Syndrome (ARDS) who are on mechanical ventilation. The study will analyze the metabolic profiles and biomarker levels of these patients to identify markers that can help forecast disease severity, mortality, and lung mechanics. It will also examine the differences in metabolic patterns between types of ARDS based on inflammation levels and pressure in the lungs. A total of 174 ARDS patients will be included, and for comparison, 50 healthy individuals undergoing routine health check-ups will serve as controls. Blood samples from both groups will be analyzed using gas chromatography mass spectrometry (GCMS) untargeted metabolomics technique. The primary outcome of the study is mortality at 28 days from ARDS diagnosis. Secondary outcomes include the length of ICU stay, and identification of metabolomic signatures associated with higher driving pressure greater than or equal to 16 cm H2O in ARDS patients. The study seeks to identify new biomarkers that can help in early diagnosis and guide treatment decisions in ARDS, especially in resource-limited settings. |