Status:
UNKNOWN
To Study Efficacy of Albumin in Cirrhosis With Spontaneous Bacterial Peritonitis at Low Risk for AKI Development
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Acute Kidney Injury
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The role of Albumin in prevention and Treatment of Acute Kidney Injury (AKI) in patients with Spontaneous Bacterial Peritonitis (SBP) who are at high risk of AKI development has been clearly defined ,...
Detailed Description
1. Aim- To compare the efficacy of albumin when compared to placebo in the development or progression of AKI in patients with cirrhosis and spontaneous bacterial peritonitis who are at low risk for AK...
Eligibility Criteria
Inclusion
- Patients who are above 18 years of age
- Patients with Cirrhosis and SBP (community acquired /Health care associated/ nosocomial) with baseline Creatinine \<1mg/dl, Bilirubin \<4mg/dl
Exclusion
- Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
- Significant cardiac failure, pulmonary disease
- Known Chronic Kidney Disease or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal USG)
- Hepatocellular carcinoma
- HIV infection;
- GI bleed within 1 month before the study
- Ileus
- Grade 3 to 4 hepatic encephalopathy
- Other types of infection
- Shock
- Serum Bilirubin ≥4 mg/dL and Serum Creatinine ≥ 1 mg/dl at presentation
- Patients requiring Albumin for any other indication.
- 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).
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04437810
Start Date
July 8 2020
End Date
April 30 2022
Last Update
January 31 2022
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070