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Low dose albumin for patients with cirrhosis and spontaneous bacterial peritonitis

Safety and efficacy of low dose albumin compared to recommended dose in patients with cirrhosis and spontaneous bacterial peritonitis - Open labelled randomized controlled trial. - MINS study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056750
Enrollment
180
Registered
2023-08-22
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K740- Hepatic fibrosis

Interventions

Intervention1: Low dose albumin: Albumin will be given at a low dose of albumin 0.5gm/kg for 3 days. Albumin (0.5g/kg) will be given for another two days in case of AKI based on IVC diameter. Control

Sponsors

AIG Hospitals
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
In-hospital mortality among both the groupsTimepoint: Duration of hospital stay

Secondary

MeasureTime frame
Change in serum Albumin level Timepoint: at day 3;Cost of albumin in each group Timepoint: For the duration of hospital stay;Duration of hospital & ICU stay. Timepoint: total duration of hospitalization & ICU stay;Incidence of adverse events in each group Timepoint: During the hospital stay;Incidence of AKI & Hepatic encephalopathy in each group. Timepoint: During the hospital stay;Proportion of patients requiring albumin infusions for an extended duration. Timepoint: at day 5;Proportion of patients responding to therapy in each group Timepoint: after 48 hours & at 5 days in case of no response at 48 hours

Countries

India

Contacts

Public ContactDr Vidish Sheth

Asian Institute of Gastroenterology Hospitals.

vidishbhaviksheth@gmail.com8849084290

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026