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
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2017
CompletedStudy Start
First participant enrolled
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2020
CompletedFebruary 20, 2020
December 1, 2019
3.5 years
April 19, 2017
February 18, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Survival in both groups
1 year
Secondary Outcomes (1)
Development of extra pulmonary organ failure during the course of study.
1 year
Study Arms (2)
Granulocyte/macrophage colony-stimulating factor (GM-CSF)
EXPERIMENTALGM 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 COMPARATORPlacebo will be given identical to the interventional
Interventions
Eligibility Criteria
You may qualify if:
- Patient with cirrhosis admitted to ICU-HDU without pneumonia at admission
- years of Age
- Child B/ C
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2017
First Posted
April 21, 2017
Study Start
April 19, 2017
Primary Completion
October 19, 2020
Study Completion
October 19, 2020
Last Updated
February 20, 2020
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share