Cirrhosis
Conditions
Brief summary
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.
Interventions
DRUGGMCSF
GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer
OTHERPlacebo
Placebo identical to GMCSF will be given
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patient with cirrhosis admitted to ICU-HDU without pneumonia at admission * 18-70 years of Age * Child B/ C
Exclusion criteria
* Patient having pneumonia * If there is evidence of preexisting chronic respiratory failure * If the patients is neutropenic (absolute neutrophil count \<1000 cells/mm3 * If there was a history of hematological malignancy or bone marrow transplantation * Person having HCC * Acute liver Failure * Pregnancy * HIV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival in both groups | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Development of extra pulmonary organ failure during the course of study. | 1 year |
Countries
India
Outcome results
None listed