Actively Recruiting
Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
Led by Institute of Liver and Biliary Sciences, India · Updated on 2024-08-09
300
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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, which decreases the morbidity and mortality. However the conventional dose recommended by the guidelines is usually not tolerated by the Indian population. Investigator propose that the low dose is as beneficial as the standard dose in patients with high risk SBP in the prevention/progression of renal dysfunction in cirrhotic patients with high risk spontaneous bacterial peritonitis. If confirmed, these results could support a significant cost reduction in the management of ascites in cirrhotic patients and decrease the side effects of the volume overload in the patient of the cirrhosis.
CONDITIONS
Official Title
Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Diagnosis of liver cirrhosis with spontaneous bacterial peritonitis (community acquired, healthcare associated, or nosocomial)
- High risk SBP defined by serum bilirubin greater than 4 mg/dL and/or serum creatinine greater than 1 mg/dL at presentation
You will not qualify if you...
- Antibiotic treatment within one week before SBP diagnosis (except prophylactic norfloxacin)
- Significant cardiac failure or pulmonary disease
- Known chronic kidney disease or signs of kidney damage (proteinuria, blood in urine, abnormal renal ultrasound)
- Presence of hepatocellular carcinoma
- HIV infection
- Gastrointestinal bleeding within one month before the study
- Grade 3 or 4 hepatic encephalopathy
- Shock with mean arterial pressure below 65
- Serum creatinine levels above 3 mg/dL
- Conditions causing dehydration such as diarrhea or strong response to diuretics within one week before SBP diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070
Actively Recruiting
Research Team
D
Dr Saurav Paul, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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