Effectiveness of albumin (biological) in Liver Disease.
- Conditions
- Health Condition 1: K77- Liver disorders in diseases classified elsewhere
- Registration Number
- CTRI/2020/03/023993
- 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
1) >18 years of age
2) Cirrhosis with SBP (community acquired, health care associated and nosocomial) and baseline serum bilirubin >=4 mg/dl or SCr >= 1 mg/dl.
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 ( Chronic Kidney Disease)or findings suggestive of organic nephropathy (proteinuria, haematuria, or Abnormal findings on renal USG)
4) Hepatocellular carcinoma
5) HIV (Human Immunodeficiency Virus) infection;
6) GI (Gastrointestinal) bleed within 1 month before the study
7) Ileus
8) Grade 3 to 4 hepatic encephalopathy
9) Other types of infection
10) Shock
11) 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).
12) Baseline serum bilirubin <4 mg/dl or S. Cr < 1 mg/dl
13) Serum creatinine level of > 3.0 mg/dl.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients having progression of Acute Kidney Injury in both groupsTimepoint: Day 7
- Secondary Outcome Measures
Name Time Method Changes in IL-6 (Inter Lukin) in both groupsTimepoint: Day 6;Changes in PRA (Plasma Renin Activity) in both groupsTimepoint: Day 6;Changes in TNF-alpha (Tumor Necrosis Factor) in both groupsTimepoint: Day 6;Development of volume overload in both groupsTimepoint: Day 7;Mortality in both groupsTimepoint: Day 7 and day 28;Resolution of Spontaneous Bacterial Peritonitis in both groupsTimepoint: Day 7