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

Not Applicable

• Conditions: Cirrhosis
• Interventions: Drug: GMCSF; Other: Placebo

• Registration Number: NCT03123666
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-19
• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-21
• Status Verified: 2019-12
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-20
• Primary Completion: 2020-10-19
• Study Completion: 2020-10-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Granulocyte/macrophage colony-stimulating factor (GM-CSF)	GMCSF	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	Placebo will be given identical to the interventional

Primary Outcome Measures

Name	Time	Method
Survival in both groups	1 year

Secondary Outcome Measures

Name	Time	Method
Development of extra pulmonary organ failure during the course of study.	1 year

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India