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GM CSF (drug) for Prevention of Pneumonia in Patients with Liver Cirrhosis

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011754
Enrollment
208
Registered
2018-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Cirrhosis Health Condition 2: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: 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 g

Sponsors

Institute of liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patient with cirrhosis admitted to ICU-HDU without pneumonia at admission 2) 18-70 years of Age 3) Child B/ C

Exclusion criteria

Exclusion criteria: 1) Patient having pneumonia 2) If there is evidence of preexisting chronic respiratory failure 3) If the patients is neutropenic (absolute neutrophil count 4) If there was a history of hematological malignancy or bone marrow transplantation 5) Person having HCC 6) Acute liver Failure 7) Pregnancy 8) HIV

Design outcomes

Primary

MeasureTime frame
Survival in both groupsTimepoint: 1 year—

Secondary

MeasureTime frame
Development of extra pulmonary organ failure during the course of study. Timepoint: 1 year;Extra pulmonary Organ Failure will be defined as per Surviving sepsis guideline 2016 Timepoint: 1 year—

Countries

India

Contacts

Public ContactDr Karan Kumar

Institute of Liver and Biliary Sciences

shivsarin@gmail.com011-46300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026