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

Primary Purpose

Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
GMCSF
Placebo
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

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

Placebo

Arm Description

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 will be given identical to the interventional

Outcomes

Primary Outcome Measures

Survival in both groups

Secondary Outcome Measures

Development of extra pulmonary organ failure during the course of study.

Full Information

First Posted
April 19, 2017
Last Updated
February 18, 2020
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT03123666
Brief Title
Recombinant Human Granulocyte Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis
Official Title
Randomized Controlled Trial of Recombinant Human Granulocye Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
October 19, 2020 (Anticipated)
Study Completion Date
October 19, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Granulocyte/macrophage colony-stimulating factor (GM-CSF)
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be given identical to the interventional
Intervention Type
Drug
Intervention Name(s)
GMCSF
Intervention Description
GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo identical to GMCSF will be given
Primary Outcome Measure Information:
Title
Survival in both groups
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Development of extra pulmonary organ failure during the course of study.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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