Health Condition 1: K77- Liver disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Low dose albumin with Standard of Care: 20% albumin.5 g/kg at diagnosis and 0.5 g/kg. Standard of Care
Control Intervention1: Standard dose albumin with standard of care: 20% albumin1.5
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
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 ( 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 13) Serum creatinine level of > 3.0 mg/dl.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients having progression of Acute Kidney Injury in both groupsTimepoint: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Manoj Kumar Sarma
Institute of Liver and Biliary Sciences
Outcome results
None listed