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

NCT06026267 | Recruiting

• 1 other identifier: ILBS-Cirrhosis-59
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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, 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

Liver Cirrhosis; Spontaneous Bacterial Peritonitis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients developing new AKI or having progression of AKI by day 4.

  Day 4

Secondary Outcomes (15)

• Resolution of Spontaneous Bacterial Peritonitis by day 5

  Day 5

• Change on Serum Ascites Albumin Gradient (SAAG) in both the groups.

  Day 5

• Change in cell count (PMN) in both groups.

  Day 5

• Changes in PRA levels from baseline to day 7

  day 7

• Changes in TNF-alpha levels from baseline to day 7

  day 7

Study Arms (2)

High Dose Arm+Standard Medical therapy

ACTIVE COMPARATOR

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.

Biological: 20% High Dose Albumin; Other: Standard Medical Treatment

Reduced Dose Albumin+Standard Medical therapy

EXPERIMENTAL

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.

Other: Standard Medical Treatment; Biological: 20% Reduced Dose Albumin

Interventions

20% High Dose Albumin BIOLOGICAL

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.

High Dose Arm+Standard Medical therapy

Standard Medical Treatment OTHER

Standard Medical Treatment

High Dose Arm+Standard Medical therapy; Reduced Dose Albumin+Standard Medical therapy

20% Reduced Dose Albumin BIOLOGICAL

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.

Reduced Dose Albumin+Standard Medical therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Albumins

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dr Saurav Paul, MD

CONTACT

01146300000; saurav.paul79@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 7, 2023
• Study Start: October 10, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

IN (1)