Comparison of the Efficacy of Granulocyte - Macrophage Colony Stimulating Factor (GM-CSF) and Norfloxacin in Secondary Prophylaxis for Spontaneous Bacterial Peritonitis - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups
研究概览
简要总结
-Consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with spontaneous bacterial peritonitis will be evaluated
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
- Double (Participant, Investigator)
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
- •Age 18 - 70years
- •Patients of decompensated liver cirrhosis who present with spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascitic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that has responded to standard medical care.
排除标准
- •Allergic to quinolones
- •Advanced HCC (Hepatocellular Carcinoma)
- •Post liver transplant
- •HIV (Human Immunodeficiency Virus) positive patients
- •Patients on immunosuppressive therapy
- •Pregnancy
- •Acute Liver Failure
- •History of hematological malignancy or bone marrow transplantation
- •No informed consent
研究组 & 干预措施
Norfloxacin with GM-CSF
Oral Norfloxacin 400mg daily and GM-CSF (Granulocyte-Macrophage colony-stimulating factor) in a dose of 1.5mcg/kg over 4 hour infusion every 15 days will be given in Group B
干预措施: GMCSF (Drug)
Norfloxacin with GM-CSF
Oral Norfloxacin 400mg daily and GM-CSF (Granulocyte-Macrophage colony-stimulating factor) in a dose of 1.5mcg/kg over 4 hour infusion every 15 days will be given in Group B
干预措施: Norfloxacin (Drug)
Norfloxacin
Patients who fulfil the inclusion criteria will receive oral norfloxacin 400 mg daily as secondary prophylaxis for SBP in Group A.
干预措施: Norfloxacin (Drug)
结局指标
主要结局
Spontaneous Bacterial Peritonitis on secondary prophylaxis in both groups
时间窗: 6 Month
Spontaneous Bacterial Peritonitis is defined as Polymorphonuclear count \> 250 in ascitic fluid
次要结局
- Survival in both groups after development of SBP (Spontaneous Bacterial Peritonitis ).(48 weeks)