NMR Based Metabolomics Kinetics in ARDS Patients
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ClinicalTrials.gov Identifier: NCT06036056 |
Recruitment Status :
Recruiting
First Posted : September 13, 2023
Last Update Posted : September 14, 2023
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Condition or disease |
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ARDS |
For this study, all adult ICU patients will be screened for ARDS. Participants who fulfill criteria of mild ARDS (PaO2/FiO2 200-300) will be considered for possible inclusion. For comparative analysis, age matched healthy control will also be included in the study. Investigators are planning to work on the blood samples collected from the participants having mild ARDS. First samples will be collected within 72 hours of fulfilling diagnostic criteria of mild ARDS, thereafter every 72 hours till participants recovered from ARDS or discharge from the ICU or three weeks after inclusion, whichever comes first. For serum preparation, 2 ml of blood samples will be obtained in collection vial, allowed to clot for 60 minutes at room temperature. The samples will then be centrifuged at 1,200 × g for 10 minutes, collected in an eppendorf tubes, sealed and frozen at minus 80 degree Celsius till NMR experiments would be performed. Further 1D and 2D NMR spectroscopic techniques will be used for the characterization and quantitation of various metabolic components of serum.
This study is exploratory in nature to understand kinetics of NMR-based metabolomics in ARDS population. Considering approximately 20-25% of mild ARDS will eventually progress to severe ARDS, investigators will include total 120 participants (including healthy participants). Data collection for comprehends demographic profile, clinical characteristics and illness severity score Sequential Organ Failure Assessment (SOFA) score at the time of study inclusion, clinical course during ICU stay and participants outcome will be done.
NMR spectroscopy (800-MHz Bruker) of sample will be performed using an external tube containing Trimethylsilyl propanoic acid (TSP), D2O to lock the signal. Plasma/Serum samples will be thawed and subsequently centrifuged at 10,000g for 5 min at 4°C to remove any solid debris, 450 μl of each sample will be thoroughly mixed with 50 μl of NMR buffer (1.5 MKH2PO4, 2 mM NaN3, 5.8 mM sodium 3-(trimethylsilyl) propionate-2,2,3,3-d4, D2O, pH 7.4) and the resulting solution will be transferred to 5 mm or 3 mm NMR tubes. All one-dimensional spectra with water suppression will be obtained. Proton spectra will be referenced to the TSP signal (δ=0.00 ppm). The Free induction decays (FIDs) will be processed with line broadening and zero filled before Fourier transformation. The acquired spectra will be manually phased; baseline corrected and integrated using TOPSPIN 2.1.
All NMR spectra will be processed and analysed using TOPSIN 3 package. Auto and supervised peak picking will be performed with Amix and metabolites identification will be done using Metaboanlayst and BIOREFCODE database of metabolites. Standard statistical supervised and unsupervised multivariate analysis (PCA and PLSDA) will be performed.
Metabolites in the 1H NMR spectra of serum samples will be assigned using 1D, 2D, HMDB and BMRB database. Small metabolite overlapping resonances present in 1D spectrum will be confirmed by using 2D spectra including heteronuclear single quantum correlation (HSQC), correlation spectroscopy (COSY), Total correlation spectroscopy (TOCSY), J-resolved (JRES) and Human Metabolome Database and Biological magnetic resonance bank (BMRB) database.
Study Type : | Observational |
Estimated Enrollment : | 120 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | NMR - Based Metabolomics Approach to Improve Clinical Management in Patients With Respiratory Failure |
Actual Study Start Date : | September 13, 2023 |
Estimated Primary Completion Date : | January 2025 |
Estimated Study Completion Date : | March 2025 |
Group/Cohort |
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Acute Respiratory Distress Syndrome
Mild Acute Respiratory Distress Syndrome
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Healthy
Healthy volunteer
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- To identify the potential biomarkers in mild ARDS using NMR based metabolomics [ Time Frame: Up to the 72 hours after the diagnosis of mild ARDS ]NMR based metabolomics in the serum of patients with mild ARDS
- To study the kinetics of NMR based metabolomics in mild ARDS and its association with progression of ARDS severity. [ Time Frame: Three weeks after diagnosing mild ARDS or till ICU discharge (whichever comes first) ]Changes in NMR based metabolomics in serum of patients with mild ARDS
- Correlation of the infection etiology and NMR based metabolomics [ Time Frame: Up to the three weeks after the diagnosis of mild ARDS or ICU discharge (whichever comes first) ]To study microorganism specific changes in NMR based metabolomics, if any
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Critically ill adult patients having mild ARDS with onset less than 72 hours
Exclusion Criteria:
- Age less than 18 years or more than 65 years
- Expected survival <72 hours
- Refusal from family member
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036056
Contact: Mohan Gurjar, MD, PDCC | +91-522-249-5403 | m.gurjar@rediffmail.com | |
Contact: Neeraj Sinha, M.Sc., Ph.D. | 05222495031 | neerajcbmr@gmail.com |
India | |
Centre of Biomedical Research | Recruiting |
Lucknow, Uttar Pradesh, India, 226014 | |
Contact: Neeraj Sinha, M.Sc., Ph.D. 05222495031 neerajcbmr@gmail.com | |
Contact: Anamika Singh anamika95singh23@gmail.com |
Principal Investigator: | Neeraj Sinha, M.Sc., Ph.D. | Centre of Biomedical Research |
Responsible Party: | Mohan Gurjar, Professor, Sanjay Gandhi Postgraduate Institute of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT06036056 |
Other Study ID Numbers: |
2023-223-CP-133 |
First Posted: | September 13, 2023 Key Record Dates |
Last Update Posted: | September 14, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Critically ill Acute respiratory distress syndrome Metabolomics Intensive care unit |