Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Sep 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of albumin, a protein that helps maintain fluid balance in the body, to see if a lower dose can be just as effective as the standard dose for patients with liver cirrhosis who are at high risk for developing a serious infection called spontaneous bacterial peritonitis (SBP). The goal is to find out if using less albumin can still help prevent kidney problems in these patients while also reducing costs and minimizing side effects.

To participate in this trial, individuals must be over 18 years old, diagnosed with cirrhosis and SBP, and have specific lab results indicating a high risk for kidney issues. However, there are certain health conditions that would exclude someone from joining, such as severe heart or lung problems, recent antibiotic use, or signs of advanced liver disease. Participants can expect close monitoring during the study to assess the effects of the treatment and contribute to important findings that could improve care for others with similar conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age \>18years
• • 2. Cirrhosis with SBP (community acquired /Health care associated/ nosocomial)
• • 3. High risk SBP : Patients with S Bil \>4 mg/dL and/or s creat \> 1 mg/dl at presentation
• 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 or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal USG)
• • 4. Hepatocellular carcinoma
• • 5. HIV infection
• • 6. GI bleed within 1 month before the study
• • 7. Grade 3 to 4 hepatic encephalopathy
• • 8. Shock (MAP \< 65)
• • 9. Serum creatinine level of \> 3 mg/decilitre
• • 10. Presence of any potential causes of dehydration (such as diarrhea or an intense response to diuretic treatment within one week before the diagnosis of SBP).