Effectiveness and safety of Glutathione injection in new onset lung problem caused by scrub typhus bacteria
- Conditions
- Health Condition 1: J158- Pneumonia due to other specified bacteria
- Registration Number
- CTRI/2023/04/051678
- Lead Sponsor
- Department of Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients aged between 18-60 years, of all gender with laboratory confirmed Scrub typhus which is evident by IgM Card test / Immunofluorescence Assay (IFA)
2. Presence of mild to moderate Acute Respiratory Distress Syndrome (ARDS) as defined by the Berlin definition:
a) Bilateral infiltrates by chest radiograph
b) Oxygen saturation of less than 94% at rest on room air or the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2 ratio) of less than 300 and more than 100, and less than 48 hours from their hospital admission.
c) Absence of other clinical conditions that could present in a similar manner (cardiogenic pulmonary oedema, non-infectious pneumonitis)
d) Absence of moribund state that would indicate imminent demise and poor chance of survival.
1. Severe ARDS with PaO2/FiO2of <100 mm Hg and need for mechanical ventilation at the time of enrolment,
2. Chronic home oxygen therapy,
3. Chronic Kidney Disease (e-GFR of <30ml/min), Chronic Liver Disease
4. Use of any other antioxidant supplement outside the protocol
5. Prior hypersensitivity to glutathione
6. Pregnancy and lactation.
7. Multi organ dysfunction syndrome on admission
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Overall mortality in intervention and control armTimepoint: At 28 days of follow-up
- Secondary Outcome Measures
Name Time Method 1. Proportion of patients needing mechanical ventilation and ventilator-free days <br/ ><br>2. Mean change of ARDS severity based on Berlin classification at 72 hours and 96 hours after intervention <br/ ><br>3. Mean change of SOFA scores at baseline, 72 and 96h after intervention <br/ ><br>4. Length of ICU stay <br/ ><br>5. Length of stay at the hospital <br/ ><br>6. Incidence of infusion-related adverse events. <br/ ><br>7. For patients who died, the number of Ventilator-free days will be 0, and for patients who are alive, the days not requiring mechanical ventilation during the 28-days will be the ventilator-free days. <br/ ><br>Timepoint: At 28 days of follow-up