NMR Based Metabolomics Kinetics in ARDS Patients

NCT06036056 | Recruiting

• 1 other identifier: 2023-223-CP-133
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS

Keywords

Critically ill; Acute respiratory distress syndrome; Metabolomics; Intensive care unit

Outcome Measures

Primary Outcomes (2)

• To identify the potential biomarkers in mild ARDS using NMR based metabolomics

  NMR based metabolomics in the serum of patients with mild ARDS

  Up to the 72 hours after the diagnosis of mild ARDS

• To study the kinetics of NMR based metabolomics in mild ARDS and its association with progression of ARDS severity.

  Changes in NMR based metabolomics in serum of patients with mild ARDS

  Three weeks after diagnosing mild ARDS or till ICU discharge (whichever comes first)

Secondary Outcomes (1)

• Correlation of the infection etiology and NMR based metabolomics

  Up to the three weeks after the diagnosis of mild ARDS or ICU discharge (whichever comes first)

Study Arms (2)

Acute Respiratory Distress Syndrome

Mild Acute Respiratory Distress Syndrome

Healthy

Healthy volunteer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Critically ill adult patients having mild ARDS with onset less than 72 hours

You may not qualify if:

• Age less than 18 years or more than 65 years
• Expected survival \<72 hours
• Refusal from family member

Sponsors & Collaborators

• Sanjay Gandhi Postgraduate Institute of Medical Sciences: lead
• Centre of BioMedical Research, India: collaborator

Study Sites (1)

Centre of Biomedical Research

Lucknow, Uttar Pradesh, 226014, India

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum of participants will be stored for future research

MeSH Terms

Conditions

Critical Illness; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Neeraj Sinha, M.Sc., Ph.D.

  Centre of Biomedical Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohan Gurjar, MD, PDCC

CONTACT

+91-522-249-5403; m.gurjar@rediffmail.com

Neeraj Sinha, M.Sc., Ph.D.

CONTACT

05222495031; neerajcbmr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 13, 2023
• Study Start: September 13, 2023
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

IN (1)