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

NCT ID: NCT03123666

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-19
• Study Completion Date: 2020-10-19

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.

Conditions

Cirrhosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: EXPERIMENTAL

GMCSF

Intervention Type: DRUG

GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer

Placebo

Placebo will be given identical to the interventional

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo identical to GMCSF will be given

Interventions

GMCSF

GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer

Intervention Type: DRUG

Placebo

Placebo identical to GMCSF will be given

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

Other Identifiers

ILBS-Cirrhosis-09

Identifier Type: -

Identifier Source: org_study_id