Efficacy of low dose of albumin (biological product) in liver cirrhosis (disease).

Phase 3

Conditions: Health Condition 1: K769- Liver disease, unspecified

Registration Number: CTRI/2023/09/057711

Lead Sponsor: Institute of Liver and Biliary Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients developing new AKI or having progression of AKI by day 4Timepoint: Day 4

Secondary Outcome Measures

Name	Time	Method
Changes in PRA, TNF-alpha,IL-6, endotoxin levels from baseline to day 7Timepoint: Day 7;Changes in ProBNP from baseline to day 4 or if shortness of breath occursTimepoint: Day 4;Changes in renal resistive index from baseline to day 7Timepoint: Day 7;Changes in vWF-Ag from baseline to day 4Timepoint: Day 4;Development of complications (esp symptomatic fluid overload, others).Timepoint: Day 90;Duration of hospital stayTimepoint: 90 days;Effect on SAAG & cell count will be observedTimepoint: Day 5;Mortality by day 7, 28 & 90 daysTimepoint: day 7, 28 & 90 days;Resolution of SBP by day 5Timepoint: Day 5