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

Status: Recruiting
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
Institute of Liver & Biliary Sciences
RECRUITING
New Delhi
Contact Information
Primary
Dr Saurav Paul, MD
saurav.paul79@gmail.com
01146300000
Time Frame
Start Date: 2023-10-10
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 300
Treatments
Active_comparator: High Dose Arm+Standard Medical therapy
Human Albumin 20% 1.5 g/kg body weight (Maximum 100g) on day 1 after the diagnosis, followed by 1 g/kg body weight (Maximum 100g)on day 3 along with standard medical therapy.
Experimental: Reduced Dose Albumin+Standard Medical therapy
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.
Sponsors
Leads: Institute of Liver and Biliary Sciences, India

This content was sourced from clinicaltrials.gov