Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.
- Conditions
- Spontaneous Bacterial Peritonitis
- Interventions
- Biological: Low Dose AlbuminBiological: Standard dose Albumin
- Registration Number
- NCT04273373
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- >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.
- 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
- Ileus
- Grade 3 to 4 hepatic encephalopathy
- Other types of infection
- Shock
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose albumin+SOC Low Dose Albumin 20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg. after 48 hours SOC (Standard of Care) Standard dose albumin+SOC Standard dose Albumin 20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours. SOC (Standard of Care)
- Primary Outcome Measures
Name Time Method Proportion of patients having new development or progression of Acute Kidney Injury in both groups Day 7
- Secondary Outcome Measures
Name Time Method 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 Number of participants who will not survive in both groups. Day 28
Trial Locations
- Locations (1)
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India