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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06026267
• Other study ID #: ILBS-Cirrhosis-59
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 5, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2023
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Sourav Paul, MD
• Phone: 01146300000
• Email: saurav.paul79[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Hypothesis Alternate Hypothesis: Low dose albumin is as effective as conventional dose albumin in cirrhosis with high risk SBP patients having AKI development or progression by day 4.

Aim:-To compare the efficacy and safety of low dose albumin with conventional dose albumin in AKI development or progression in patients with cirrhosis and high risk spontaneous bacterial peritonitis.

Study population: Patients of age > 18 years of age with cirrhosis of liver who are admitted in ward/ICU diagnosed with high risk SBP.

Study design: Randomized controlled trial Study period:1.5year Sample size: 300 (150 cases in each group) Assuming that the rate of AKI development in conventional dose albumin group - 10% and low dose albumin group 15%, Power- 80%, Alpha- 10% ONE SIDED, Non inferiority limit- 5, cases needed to enroll are 270, further assuming 10% dropout, investigator decided to enroll total 300 cases, randomly allocated with 150 cases in each arm by block randomization method with Block size of 10 Cases will be randomly allocated in 2 groups by block randomization method with block size taken as 10.

STATISTICAL ANALYSIS:

Continuous variables- Mean +/- SD Categorical variables as percentages (%) or Frequencies Student t test will be applied in continuous data compared with two groups Survival analysis like Cox-Regression model and Kaplan-Meir plots will be plotted to find the possible factors responsible for mortality Besides these, Intent to treat (ITT) and Per Protocol (PP) will be done at the time of data analysis.

Adverse effects:

Patients receiving Albumin may experience Nausea, Vomiting, Fever with chills, dyspnea Wheezing, Volume overload, Anaphylactic reaction

Stopping rule of study:

Adverse reaction to drug Cardiopulmonary compromise

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Peritonitis
• Spontaneous Bacterial Peritonitis

Intervention

Biological:
• 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

Other:
• Standard Medical Treatment
Standard Medical Treatment

Biological:
• 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

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients developing new AKI or having progression of AKI by day 4.		Day 4
Secondary	Resolution of Spontaneous Bacterial Peritonitis by day 5	Resolution is defined as decrease in ascitic fluid PMN > 25% from baseline	Day 5
Secondary	Change on Serum Ascites Albumin Gradient (SAAG) in both the groups.		Day 5
Secondary	Change in cell count (PMN) in both groups.		Day 5
Secondary	Changes in PRA levels from baseline to day 7		day 7
Secondary	Changes in TNF-alpha levels from baseline to day 7		day 7
Secondary	Changes in IL-6 levels from baseline to day 7		day 7
Secondary	Changes in endotoxin levels from baseline to day 7		day 7
Secondary	Changes in renal resistive index from baseline to day 7		day 7
Secondary	Number of patients with development of complications in both groups		90 days
Secondary	Number of Participants with changes in ProBNP from baseline to day 4 or if shortness of breath occurs		Day 4
Secondary	Number of Participants with changes in vWF-Ag from baseline to day 4		Day 4
Secondary	Number of patients expired in both the groups		Day 7
Secondary	Number of patients expired in both the groups		Day 28
Secondary	Number of patients expired in both the groups		Day 90
Secondary	Duration of hospital stay		90 days