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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03123666
• Other study ID #: ILBS-Cirrhosis-09
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: October 19, 2020

Study information

• Verified date: December 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: October 19, 2020
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival in both groups		1 year
Secondary	Development of extra pulmonary organ failure during the course of study.		1 year