跳至主要内容
临床试验/NCT03123666
NCT03123666Unknown不适用

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

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2017年4月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
Survival in both groups

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with cirrhosis admitted to ICU-HDU without pneumonia at admission
  • 18-70 years of Age
  • Child B/ C

排除标准

  • 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

研究组 & 干预措施

Placebo

Placebo Comparator

Placebo will be given identical to the interventional

干预措施: Placebo (Other)

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

Experimental

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

干预措施: GMCSF (Drug)

结局指标

主要结局

Survival in both groups

时间窗: 1 year

次要结局

  • Development of extra pulmonary organ failure during the course of study.(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验