Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Proportion of patients developing new AKI or having progression of AKI by day 4.
研究概览
简要总结
The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined, which decreases the morbidity and mortality. However the conventional dose recommended by the guidelines is usually not tolerated by the Indian population. Investigator propose that the low dose is as beneficial as the standard dose in patients with high risk SBP in the prevention/progression of renal dysfunction in cirrhotic patients with high risk spontaneous bacterial peritonitis. If confirmed, these results could support a significant cost reduction in the management of ascites in cirrhotic patients and decrease the side effects of the volume overload in the patient of the cirrhosis.
详细描述
Hypothesis Alternate Hypothesis: Low dose albumin is as effective as conventional dose albumin in cirrhosis with high risk SBP patients having AKI development or progression by day 4.
Aim:-To compare the efficacy and safety of low dose albumin with conventional dose albumin in AKI development or progression in patients with cirrhosis and high risk spontaneous bacterial peritonitis.
Study population: Patients of age > 18 years of age with cirrhosis of liver who are admitted in ward/ICU diagnosed with high risk SBP.
Study design: Randomized controlled trial Study period:1.5year Sample size: 300 (150 cases in each group) Assuming that the rate of AKI development in conventional dose albumin group - 10% and low dose albumin group 15%, Power- 80%, Alpha- 10% ONE SIDED, Non inferiority limit- 5, cases needed to enroll are 270, further assuming 10% dropout, investigator decided to enroll total 300 cases, randomly allocated with 150 cases in each arm by block randomization method with Block size of 10 Cases will be randomly allocated in 2 groups by block randomization method with block size taken as 10.
STATISTICAL ANALYSIS:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18years
- •Cirrhosis with SBP (community acquired /Health care associated/ nosocomial)
- •High risk SBP : Patients with S Bil >4 mg/dL and/or s creat > 1 mg/dl at presentation
排除标准
- •Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
- •Significant cardiac failure, pulmonary disease
- •Known CKD or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal USG)
- •Hepatocellular carcinoma
- •HIV infection
- •GI bleed within 1 month before the study
- •Grade 3 to 4 hepatic encephalopathy
- •Shock (MAP < 65)
- •Serum creatinine level of > 3 mg/decilitre
- •Presence of any potential causes of dehydration (such as diarrhea or an intense response to diuretic treatment within one week before the diagnosis of SBP).
结局指标
主要结局
Proportion of patients developing new AKI or having progression of AKI by day 4.
时间窗: Day 4
次要结局
- Number of patients expired in both the groups(Day 90)
- Duration of hospital stay(90 days)
- Resolution of Spontaneous Bacterial Peritonitis by day 5(Day 5)
- Change on Serum Ascites Albumin Gradient (SAAG) in both the groups.(Day 5)
- Changes in TNF-alpha levels from baseline to day 7(day 7)
- Changes in renal resistive index from baseline to day 7(day 7)
- Change in cell count (PMN) in both groups.(Day 5)
- Changes in PRA levels from baseline to day 7(day 7)
- Changes in IL-6 levels from baseline to day 7(day 7)
- Changes in endotoxin levels from baseline to day 7(day 7)
- Number of patients with development of complications in both groups(90 days)
- Number of Participants with changes in ProBNP from baseline to day 4 or if shortness of breath occurs(Day 4)
- Number of Participants with changes in vWF-Ag from baseline to day 4(Day 4)