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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Cirrhosis

Treatments: Drug: GMCSF; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03123666

ILBS-Cirrhosis-09

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups, including a placebo group

Granulocyte/macrophage colony-stimulating factor (GM-CSF)

Experimental group

Description:

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

Treatment:

Drug: GMCSF

Placebo

Placebo Comparator group

Description:

Placebo will be given identical to the interventional

Treatment:

Other: Placebo