Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
ILBS-Cirrhosis-59
Description
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.
Trial arms
Trial start
2023-09-05
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Not yet recruiting
Treatment
20% 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
Arms:
High Dose Arm
Standard Medical Treatment
Standard Medical Treatment
Arms:
High Dose Arm, Reduced Dose Albumin+Standard Medical therapy
20% 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
Arms:
Reduced Dose Albumin+Standard Medical therapy
Size
300
Primary endpoint
Proportion of patients developing new AKI or having progression of AKI by day 4.
Day 4
Eligibility criteria
Inclusion Criteria: 1. Age \>18years 2. Cirrhosis with SBP (community acquired /Health care associated/ nosocomial) 3. High risk SBP : Patients with S Bil \>4 mg/dL and/or s creat \> 1 mg/dl at presentation Exclusion Criteria: 1. Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin) 2. Significant cardiac failure, pulmonary disease 3. Known CKD or findings suggestive of organic nephropathy (proteinuria, haematuria, or abnormal findings on renal USG) 4. Hepatocellular carcinoma 5. HIV infection 6. GI bleed within 1 month before the study 7. Grade 3 to 4 hepatic encephalopathy 8. Shock (MAP \< 65) 9. Serum creatinine level of \> 3 mg/decilitre 10. 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).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}
Updated at
2023-09-13

1 organization

2 products

2 indications

Organization
Institute of Liver and Biliary Sciences
Product
20% High Dose Albumin
Indication
Cirrhosis
Indication
Spontaneous Bacterial Peritonitis
Product
20% Reduced Dose Albumin