AIM:- A randomized non-inferiority trial comparing low dose albumin versus standard dose albumin in Spontaneous Bacterial Peritonitis with acute kidney injury
Methodology In this non-inferior randomized controlled trial one group will receive Low dose albumin: 20% albumin.5 g/kg at diagnosis and 0.5 g/kg till 5 days and other group will receive Standard dose albumin: 20% albumin1.5 g/kg at diagnosis and 1 g/kg at 48 h (duration of infusion 24 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 progression of Acute Kidney Injury by day 7
| Condition | Spontaneous Bacterial Peritonitis |
|---|---|
| Treatment | Low Dose Albumin, Standard dose Albumin |
| Clinical Study Identifier | NCT04273373 |
| Sponsor | Institute of Liver and Biliary Sciences, India |
| Last Modified on | 8 March 2021 |
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