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Informed consent obtained from the patient or the patient's legal surrogate. The window for randomization and initiation of study drug infusion is 2 days from day of Admission. All further time points are relative to the day of randomization. Patients will be randomized (1:1) to receive either recombinant human GM-CSF or placebo. Using randomized block design of 10 each generated by computer and provided in sequential, sealed, opaque envelopes. Subjects will be stratified based on Child status. Patients who fulfil the inclusion criteria will receive either slow IV infusion of GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer for 7 days OR Placebo(saline infusion and saline nebulization). Standard medical care will be given in both limbs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granulocyte/macrophage colony-stimulating factor (GM-CSF) | Experimental | GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer OR Placebo for 7 days. Both the groups will receive standard medical care |
|
| Placebo | Placebo Comparator | Placebo will be given identical to the interventional |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GMCSF | Drug | GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survival in both groups | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Development of extra pulmonary organ failure during the course of study. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Other | Placebo identical to GMCSF will be given |
|