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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
Sponsor:
Collaborator:
Centre of BioMedical Research, India
Information provided by (Responsible Party):
Mohan Gurjar, Sanjay Gandhi Postgraduate Institute of Medical Sciences

Study Description
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Brief Summary:
Acute respiratory distress syndrome (ARDS) is a life-threatening condition requiring respiratory support to maintain oxygenation. Very few biomarkers about ARDS have been identified but none of them has a sufficient specificity or sensitivity to characterize by itself the severity of lung condition. Investigators hypothesize that there is considerable change occurring in metabolic profiles in mild, moderate, and severe ARDS in comparison to healthy cohort, which can be detectable through serum analysis using NMR based metabolomics study. This research would help to understand metabolomics kinetics during the ARDS disease progression. Overall, NMR-based metabolomics study would provide an insight into the mediators involved in pathogenesis and progression of ARDS.

Condition or disease
ARDS

Detailed Description:

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 Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Acute Respiratory Distress Syndrome
Mild Acute Respiratory Distress Syndrome
Healthy
Healthy volunteer


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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
Serum of participants will be stored for future research

Eligibility Criteria
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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
Study Population
Patients who fulfill criteria of mild ARDS (PaO2/FiO2 200-300) will be considered for possible inclusion. For comparative analysis, age matched healthy control (from healthy blood donor volunteer will also be included in the study.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Mohan Gurjar, MD, PDCC +91-522-249-5403 m.gurjar@rediffmail.com
Contact: Neeraj Sinha, M.Sc., Ph.D. 05222495031 neerajcbmr@gmail.com

Locations
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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   
Sponsors and Collaborators
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Centre of BioMedical Research, India
Investigators
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Principal Investigator: Neeraj Sinha, M.Sc., Ph.D. Centre of Biomedical Research
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohan Gurjar, Sanjay Gandhi Postgraduate Institute of Medical Sciences:
Critically ill
Acute respiratory distress syndrome
Metabolomics
Intensive care unit