Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: ALbumin with SMT: Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, foll
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patients who are above 18 years of age 2) Patients with Cirrhosis and SBP (community acquired /Health care associated/ nosocomial) with baseline Creatinine <1mg/dl, Bilirubin <4mg/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 Chronic Kidney Disease 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 Ileus 7) Grade 3 to 4 hepatic encephalopathy 8) Other types of infection 9) Shock 10) Serum Bilirubin >=4 mg/dL and Serum Creatinine >= 1 mg/dl at presentation 11) Patients requiring Albumin for any other indication. 12) 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 having development / progression of Acute Kidney Injury in both groups.Timepoint: Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PRA,TNF alpha & IL-6 in both groupsTimepoint: Day 7;Change in Renal resistive index in both groupsTimepoint: Day 7;Mortality in both groupsTimepoint: Day 7 and Day 28;Resolution of Spotaneous Bacterial Peroitonoitis in both groupsTimepoint: Day 2 and Day 7 | — |
Countries
India
Contacts
Public ContactDr Manoj Kumar Sharma
Institute of Liver and Biliary Sciences
Outcome results
None listed