Randomized Controlled Trial of Recombinant Human Granulocye Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis
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
- 否
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 will be given identical to the interventional
干预措施: Placebo (Other)
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 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)
