ow dose albumin for patients with cirrhosis and spontaneous bacterial peritonitis
Phase 3
- Conditions
- Health Condition 1: K740- Hepatic fibrosis
- Registration Number
- CTRI/2023/08/056750
- Lead Sponsor
- AIG Hospitals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patient >18 years age and cirrhosis and ascites with PMN count >250/cumm in the absence of secondary bacterial peritonitis. Patient with SBP diagnosed in our hospital.
Exclusion Criteria
Patients less than 18 years of age
Hepatocellular carcinoma or peritoneal carcinomatosis
Tuberculosis, pancreatitis or bleeding into ascitic fluid (which can elevate the PMN count in ascitic fluid).
Cardiac or end-stage kidney disease.
Patients with SBP diagnosed in outside hospital
Secondary bacterial peritonitis.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In-hospital mortality among both the groupsTimepoint: Duration of hospital stay
- Secondary Outcome Measures
Name Time Method Change in serum Albumin level <br/ ><br>Timepoint: at day 3;Cost of albumin in each group <br/ ><br>Timepoint: For the duration of hospital stay;Duration of hospital & ICU stay. <br/ ><br>Timepoint: total duration of hospitalization & ICU stay;Incidence of adverse events in each group <br/ ><br>Timepoint: During the hospital stay;Incidence of AKI & Hepatic encephalopathy in each group. <br/ ><br>Timepoint: During the hospital stay;Proportion of patients requiring albumin infusions for an extended duration. <br/ ><br>Timepoint: at day 5;Proportion of patients responding to therapy in each group <br/ ><br>Timepoint: after 48 hours & at 5 days in case of no response at 48 hours