Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-04 @ 10:11 PM
Study NCT ID:
NCT06026267
Status:
RECRUITING
Last Update Posted:
2024-08-09
First Post:
2023-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Organization:
Study Overview
Official Title:
Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: