Effect of Injection Dexamethasone in ICU admitted patients of Acute Respiratory Distress Syndrome and assessing the outcome post intervention.

Effect of Dexamethasone in metabolomics and pro inflammatory markers in patients of Acute Respiratory Distress Syndrome. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092553

Enrollment

Registered

2025-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J80- Acute respiratory distress syndrome

Interventions

Intervention1: Injection Dexamethasone 20 mg IV OD for first 5 days followed by 10 mg IV OD next 5 days.: Injection Dexamethasone 20 mg IV OD given to ARDS patients on 1st 5 days followed by 10 mg IV

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients requiring ICU admission. 2. Patients suffering from ARDS (as per Global Definition of ARDS). 3. Patients aged 18-65 years of age from either gender. 4. Subject (or legally authorised person) gives a written informed consent.

Exclusion criteria

Exclusion criteria: 1. Any contraindication to the procedure of mini BAL like severe hypoxemia. 2. Patients having coagulopathy. 3. Patients on immunosuppressants. 4. Patients who had previous steroid therapy. 5. Patients with a concomitant medical condition, whose participation may create an additional unacceptable risk. 6. Patients on anti inflammatory drugs.

Design outcomes

Primary

Measure	Time frame
To study the effect of Dexamethasone in Acute Respiratory Distress Syndrome on metabolomics and pro inflammatory markers using mini Broncho Alveolar Lavage and serum.Timepoint: Metabolomics and Pro Inflammatory markers to be assessed at, 1. Baseline (Day 0) 2. Day 3 3. Day 7 4. Day of extubation	—

Secondary

Measure	Time frame
1. All-cause mortality till day 28. 2. All-cause mortality till day 90. 3. Duration of mechanical ventilation. 4. Duration of hospitalisation.Timepoint: After enrolling the patients in this study as per the inclusion criteria, we will send all routine investigations along with mini BAL for metabolomics screening and pro-inflammatory markers through NMR spectroscopy as well as for pro inflammatory markers (IL-6), then we will repeat these investigations during the study period (After making diagnosis of ARDS, Day 3, Day 7, Day of extubation) The patients will be randomised in balance to receive either Dexamethasone or distilled water in injection.	—

Measure

Time frame

1. All-cause mortality till day 28. 2. All-cause mortality till day 90. 3. Duration of mechanical ventilation. 4. Duration of hospitalisation.Timepoint: After enrolling the patients in this study as per the inclusion criteria, we will send all routine investigations along with mini BAL for metabolomics screening and pro-inflammatory markers through NMR spectroscopy as well as for pro inflammatory markers (IL-6), then we will repeat these investigations during the study period (After making diagnosis of ARDS, Day 3, Day 7, Day of extubation) The patients will be randomised in balance to receive either Dexamethasone or distilled water in injection.

—

Countries

India

Contacts

Public ContactProf Bikram Kumar Gupta

Institute of Medical Sciences, BHU, Varanasi

bikramgupta03@gmail.com8400100128

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026