A Randomized Non-inferiority Trial Comparing Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Proportion of patients having new development or progression of Acute Kidney Injury in both groups
研究概览
简要总结
AIM:- A randomized non-inferiority trial comparing low dose albumin versus standard dose albumin in high risk Spontaneous Bacterial Peritonitis.
Methodology In this non-inferior randomized controlled trial one group will receive Low dose albumin: 20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours and other group will receive Standard dose albumin: 20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 h (duration of infusion 6 hours).
Study population: Patients of age > 18 years of age with cirrhosis of liver who are admitted in ward/Intensive Care Unit diagnosed with Spontaneous Bacterial Peritonitis.
Study design: Randomized controlled trial Study period: September 2019- September 2020 Sample size: 300 (150 cases in each group) If there is a true difference in favour of the experimental treatment of 5 % then 270 patients are required to be 80% sure that the upper limit of a one sided 95% confidence interval (or equivalently a 90 % two-sided confidence interval) will exclude a difference in favour of the standard group of more than 5 %. And if the investigators consider 10% drop out final sample size is 270+30=300. 150 in each limb. Cases will be randomly allocated in 2 groups by block randomization method with block size taken as 10.
Monitoring and assessment: all the parameters of the objective and also noted any adverse effects.
Adverse Effects: Nausea, Vomiting, Fever with chills, dyspnea Stopping Rule: in the event of any of the adverse effects during therapy.
Expected Outcome of the project:
Proportion of patients having new development or progression of Acute Kidney Injury by day 7
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Cirrhosis with SBP (community acquired, health care associated and nosocomial) and baseline serum bilirubin ≥4 mg/dl and/or SCr ≥ 1 mg/dl.
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 ( Chronic Kidney Disease)or findings suggestive of organic nephropathy (proteinuria, haematuria, or Abnormal findings on renal USG)
- •Hepatocellular carcinoma
- •HIV (Human Immunodeficiency Virus) infection;
- •GI (Gastrointestinal) bleed within 1 month before the study
- •Grade 3 to 4 hepatic encephalopathy
- •Other types of infection
- •Presence of any potential causes of dehydration (such as diarrhoea or an intense response to diuretic treatment) within one week before the diagnosis of SBP).
- •Baseline serum bilirubin <4 mg/dl or S. Cr < 1 mg/dl
- •Serum creatinine level of > 3.0 mg/dl.
结局指标
主要结局
Proportion of patients having new development or progression of Acute Kidney Injury in both groups
时间窗: Day 7
次要结局
- Number of participants who will not survive in both groups.(Day 28)
- Number of participants who will develop volume overload in both groups(Day 7)
- Number of participants with resolution of Spontaneous Bacterial Peritonitis in both groups(Day 7)
- Changes in RRI (Renal Resistive Index) in both groups(Day 6)