Low Dose Albumin Versus Standard Dose Albumin in Spontaneous Bacterial Peritonitis With Acute Kidney Injury.
Low Dose Albumin Versus Standard Dose Albumin in Spontaneous Bacterial Peritonitis With Acute Kidney Injury.
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
Inclusion Criteria:

 1. >18 years of age

 2. Cirrhosis with SBP (community acquired, health care associated and nosocomial) and
 baseline serum bilirubin ≥4 mg/dl or SCr ≥ 1 mg/dl.

 Exclusion Criteria:

 1. Antibiotic treatment within one week before the diagnosis of SBP (except for
 prophylactic treatment with norfloxacin)

 2. Significant cardiac failure, pulmonary disease

 3. Known CKD ( Chronic Kidney Disease)or findings suggestive of organic nephropathy
 (proteinuria, haematuria, or Abnormal findings on renal USG)

 4. Hepatocellular carcinoma

 5. HIV (Human Immunodeficiency Virus) infection;

 6. GI (Gastrointestinal) bleed within 1 month before the study

 7. Ileus

 8. Grade 3 to 4 hepatic encephalopathy

 9. Other types of infection

 10. Shock

 11. 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).

 12. Baseline serum bilirubin <4 mg/dl or S. Cr < 1 mg/dl

 13. Serum creatinine level of > 3.0 mg/dl.