Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06036056
Status:
RECRUITING
Last Update Posted:
2023-09-14
First Post:
2023-08-31
Brief Title:
NMR Based Metabolomics Kinetics in ARDS Patients
Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Organization:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Study Overview
Official Title:
NMR - Based Metabolomics Approach to Improve Clinical Management in Patients With Respiratory Failure
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
For this study all adult ICU patients will be screened for ARDS Participants who fulfill criteria of mild ARDS PaO2FiO2 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 1200 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 PlasmaSerum samples will be thawed and subsequently centrifuged at 10000g for 5 min at 4C to remove any solid debris 450 μl of each sample will be thoroughly mixed with 50 μl of NMR buffer 15 MKH2PO4 2 mM NaN3 58 mM sodium 3-trimethylsilyl propionate-2233-d4 D2O pH 74 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 δ000 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 21
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
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 PlasmaSerum samples will be thawed and subsequently centrifuged at 10000g for 5 min at 4C to remove any solid debris 450 μl of each sample will be thoroughly mixed with 50 μl of NMR buffer 15 MKH2PO4 2 mM NaN3 58 mM sodium 3-trimethylsilyl propionate-2233-d4 D2O pH 74 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 δ000 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 21
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None