RecruitingNot ApplicableNCT06026267

Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis

Sponsor

Institute of Liver and Biliary Sciences, India

Enrollment

300 participants

Start Date

Oct 10, 2023

Study Type

INTERVENTIONAL

Conditions

Liver Cirrhosis

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, 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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

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 Criteria10

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).

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Interventions

BIOLOGICAL20% High Dose Albumin

A\]. Patients in the conventional albumin Arm will receive Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg bodyweight (Maximum 100g)on day 3 along with standard medical therapy. Duration of albumin over 24 hours.

OTHERStandard Medical Treatment

Standard Medical Treatment

BIOLOGICAL20% Reduced Dose Albumin

B\]. Patients in the low dose albumin Arm will receive Human Albumin 20% 1.0 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 0.5 g/kg bodyweight (Maximum 100g) on day 3 along with standard medical therapy. Duration of albumin over 24 hours.