Status:
RECRUITING
Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Spontaneous Bacterial Peritonitis
Eligibility:
All Genders
18-75 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
Hypothesis Alternate Hypothesis: Low dose albumin is as effective as conventional dose albumin in cirrhosis with high risk SBP patients having AKI development or progression by day 4. Aim:-To compare...
Eligibility Criteria
Inclusion
- Age \>18years
- Cirrhosis with SBP (community acquired /Health care associated/ nosocomial)
- High risk SBP : Patients with S Bil \>4 mg/dL and/or s creat \> 1 mg/dl at presentation
Exclusion
- Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
- Significant cardiac failure, pulmonary disease
- Known CKD 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
- Grade 3 to 4 hepatic encephalopathy
- Shock (MAP \< 65)
- Serum creatinine level of \> 3 mg/decilitre
- 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 :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06026267
Start Date
October 10 2023
End Date
December 31 2024
Last Update
August 9 2024
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070