| CTRI Number |
CTRI/2024/10/074568 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of metabolomic profile in trauma and non trauma patients having ARDS using NMR spectroscopy |
|
Scientific Title of Study
|
A comparative study of metabolomic profile in trauma vs non trauma patients having ARDS in ICU using NMR spectroscopy
|
| 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 Alankriti Mishra |
| Designation |
Junior Resident |
| Affiliation |
Institute of medical sciences BHU |
| Address |
1st floor Department of Anaesthesiology IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
dr.alankritimishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjaree Mishra |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anaesthesiology
Trauma and superspeciality hospital
IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452030626 |
| Fax |
|
| Email |
mnajari@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjaree Mishra |
| Designation |
Professor |
| Affiliation |
Institute of medical sciences BHU |
| Address |
Department of Anaesthesiology
Trauma and superspeciality hospital
IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9452030626 |
| Fax |
|
| Email |
mnajari@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, BHU, Varanasi, Uttar Pradesh, India
Pin -221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences BHU |
| Address |
1st floor
Department of Anaesthesiology
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Uttar Pradesh
India Pin- 221005 |
| Type of Sponsor |
Research institution and 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 Manjaree Mishra |
Institute of medical sciences BHU |
First floor, department of Anaesthesiology
Varanasi
UTTAR PRADESH |
9452030626
mnajari@bhu.ac.im |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IMS BHU |
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 |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ARDS patients diagnosed by berlin criteria or new global definition of ARDS
Admitted in ICU and on ventilator support for more than 24 hours
Patients or relatives giving written informed consent for study |
|
| ExclusionCriteria |
| Details |
Age less than 18 years or more than 65 years
Pregnancy
Patient or relatives refusal |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare metabolomics profile between different etiologies of ARDS traumatic and non traumatic |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical correlation in terms of ventilatory parameters, length of ICU stay & mortality |
18 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
09/10/2024 |
| 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="6"
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
|
ARDS is one of the major cause of deaths in ICU. Due to multiple etiological factors it’s even more challenging to understand ARDS in terms of progression, prognostication and outcome prediction. Metabolomics is an emerging approach for identifying and quantifying metabolites in biofluids, cells, and tissues. It allows for the simultaneous evaluation of a large set of metabolites/biological compounds in a single sample, thus providing an integrative snapshot view of biological systems. ARDS is a clinical syndrome characterized by acute hypoxemic respiratory failure due to lung inflammation, pulmonary vascular hyper permeability, non-cardiogenic pulmonary edema secondary to direct or indirect lung injury, including sepsis, pneumonia, trauma, aspiration pneumonia, pancreatitis, and other critical clinical conditions. This observational cross sectional study aims to better understand the clinical effect of causative factors of ARDS using NMR based metabolomics and setup metabolite credentials for the same. |