Health Condition 1: K769- Liver disease, unspecified
Conditions
Interventions
Intervention1: High Dose Albumin with Standard Medical therapy: Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg body weight (Maximum 100g)on day
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion 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
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 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients developing new AKI or having progression of AKI by day 4Timepoint: Day 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Manoj Kumar Sharma
Institute of Liver and Biliary Sciences
Outcome results
None listed