NCT02468089已完成不适用
A Randomized Study to Compare the Efficacy of Carbepenem Versus Carbepenem Plus GM-CSF in Difficult To Treat Spontaneous Bacterial Peritonitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)
研究概览
简要总结
A Minimum of 150 consecutive patients of decompensated cirrhosis of any etiology, presenting to the Institute of Liver and Biliary Sciences hospital with a diagnosis of difficult to treat SBP will be included and randomized into two treatment groups.
Group A - Carbepenem+albumin Group B - Carbepenem+albumin+GMCSF.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 18 years
- •Patients of decompensated liver cirrhosis who present with- Spontaneous bacterial peritonitis (Presence of more than 250 neutrophils per cc of ascetic fluid, in the absence of a surgical abdomen, in the presence of decompensated cirrhosis and portal hypertension) that is not responding to initial therapy- DTT-SBP:
- •Hospital acquired - New onset SBP (Spontaneous bacterial peritonitis) after 48 h of hospitalization.
- •Recurrent SBP - One or more prior episode(s) of SBP in year.
- •Antibiotic resistant - Resistance to 3rd Gen Cephalosporin in last 3 m.
- •Antibiotic non-response -Non-response to 3rd Gen Cephalosporin, sepsis on 3rd Gen Cephalosporin.
排除标准
- •< 18 years.
- •Advanced HCC (HepatoCellular Carcinoma)
- •Post liver transplant
- •HIV + ve, Immunosuppressive therapy
- •Domiciliary treatment
研究组 & 干预措施
Carbepenem+albumin+GMCSF.
Experimental
干预措施: Carbepenem (Drug)
Carbepenem+albumin+GMCSF.
Experimental
干预措施: Albumin (Drug)
Carbepenem+albumin+GMCSF.
Experimental
干预措施: GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) . (Drug)
Carbepenem+albumin
Active Comparator
干预措施: Carbepenem (Drug)
Carbepenem+albumin
Active Comparator
干预措施: Albumin (Drug)
结局指标
主要结局
Total no of patients cured from SBP (Spontaneous Bacterial Peritonitis)
时间窗: 1 week
次要结局
- Survival at week 2(week 2)
- Survival at week 12(week 12)
- Survival at week 4(week 4)
- Total number of patients develop variceal bleed.(1 week)
- Total number of patients develop non-SBP (Spontaneous Bacterial Peritonitis) infections within 1 wk of enrolment.(1 week)
- Total number of patients develop HE (Hepatic Encephalopathy).(1 week)
- Total number of patients develop AKI (Acute kidney Injury).(1 week)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in CirrhosisCirrhosisNCT01212250Institute of Liver and Biliary Sciences, India132
已完成
不适用
Advanced Carbohydrate Counting and Automated Bolus CalculationType 1 DiabetesNCT02084498Steno Diabetes Center Copenhagen178
已完成
3 期
Prevent/Delay Development of Type 2 Diabetes in Subjects With Impaired Glucose Homeostasis Treated With Acarbose in Primary CareDiabetes MellitusNCT01010100Bayer204
Unknown
4 期
The Investigation of Peginterferon Alfa-2a on Optimal in Chronic Hepatitis B Patients Who Have a High Risk of HCCHepatitis BNCT03084250Shanghai Nanhui Nanhua Hospital150
已完成
4 期
Carbohydrate Antigen 125-guided Therapy in Heart FailureHeart FailureNCT02008110Fundación para la Investigación del Hospital Clínico de Valencia360