NCT03123666

Recombinant Human Granulocyte Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis

Randomized Controlled Trial of Recombinant Human Granulocye Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DRUG	GMCSF	GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer
OTHER	Placebo	Placebo identical to GMCSF will be given

Timeline

• Start date: 2017-04-19
• Primary completion: 2020-10-19
• Completion: 2020-10-19
• First posted: 2017-04-21
• Last updated: 2020-02-20

Locations

1 site across 1 country: India