Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.
Primary Purpose
Spontaneous Bacterial Peritonitis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Low Dose Albumin
Standard dose Albumin
Sponsored by
About this trial
This is an interventional treatment trial for Spontaneous Bacterial Peritonitis
Eligibility Criteria
Inclusion Criteria:
- >18 years of age
- Cirrhosis with SBP (community acquired, health care associated and nosocomial) and baseline serum bilirubin ≥4 mg/dl and/or SCr ≥ 1 mg/dl.
Exclusion Criteria:
- Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
- Significant cardiac failure, pulmonary disease
- Known CKD ( Chronic Kidney Disease)or findings suggestive of organic nephropathy (proteinuria, haematuria, or Abnormal findings on renal USG)
- Hepatocellular carcinoma
- HIV (Human Immunodeficiency Virus) infection;
- GI (Gastrointestinal) bleed within 1 month before the study
- Ileus
- Grade 3 to 4 hepatic encephalopathy
- Other types of infection
- Shock
- Presence of any potential causes of dehydration (such as diarrhoea or an intense response to diuretic treatment) within one week before the diagnosis of SBP).
- Baseline serum bilirubin <4 mg/dl or S. Cr < 1 mg/dl
- Serum creatinine level of > 3.0 mg/dl.
Sites / Locations
- Institute of Liver and Biliary Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard dose albumin+SOC
Low dose albumin+SOC
Arm Description
20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours. SOC (Standard of Care)
20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg. after 48 hours SOC (Standard of Care)
Outcomes
Primary Outcome Measures
Proportion of patients having new development or progression of Acute Kidney Injury in both groups
Secondary Outcome Measures
Number of participants with resolution of Spontaneous Bacterial Peritonitis in both groups
Changes in RRI (Renal Resistive Index) in both groups
Number of participants who will develop volume overload in both groups
Number of participants who will not survive in both groups.
Number of participants who will not survive in both groups.
Full Information
NCT ID
NCT04273373
First Posted
February 12, 2020
Last Updated
May 4, 2022
Sponsor
Institute of Liver and Biliary Sciences, India
1. Study Identification
Unique Protocol Identification Number
NCT04273373
Brief Title
Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.
Official Title
A Randomized Non-inferiority Trial Comparing Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
AIM:- A randomized non-inferiority trial comparing low dose albumin versus standard dose albumin in high risk Spontaneous Bacterial Peritonitis.
Methodology In this non-inferior randomized controlled trial one group will receive Low dose albumin: 20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours and other group will receive Standard dose albumin: 20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 h (duration of infusion 6 hours).
Study population: Patients of age > 18 years of age with cirrhosis of liver who are admitted in ward/Intensive Care Unit diagnosed with Spontaneous Bacterial Peritonitis.
Study design: Randomized controlled trial Study period: September 2019- September 2020 Sample size: 300 (150 cases in each group) If there is a true difference in favour of the experimental treatment of 5 % then 270 patients are required to be 80% sure that the upper limit of a one sided 95% confidence interval (or equivalently a 90 % two-sided confidence interval) will exclude a difference in favour of the standard group of more than 5 %. And if the investigators consider 10% drop out final sample size is 270+30=300. 150 in each limb. Cases will be randomly allocated in 2 groups by block randomization method with block size taken as 10.
Monitoring and assessment: all the parameters of the objective and also noted any adverse effects.
Adverse Effects: Nausea, Vomiting, Fever with chills, dyspnea Stopping Rule: in the event of any of the adverse effects during therapy.
Expected Outcome of the project:
Proportion of patients having new development or progression of Acute Kidney Injury by day 7
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Bacterial Peritonitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard dose albumin+SOC
Arm Type
Active Comparator
Arm Description
20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours. SOC (Standard of Care)
Arm Title
Low dose albumin+SOC
Arm Type
Experimental
Arm Description
20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg. after 48 hours SOC (Standard of Care)
Intervention Type
Biological
Intervention Name(s)
Low Dose Albumin
Intervention Description
20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours
Intervention Type
Biological
Intervention Name(s)
Standard dose Albumin
Intervention Description
20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours (duration of infusion 6 hours).
Primary Outcome Measure Information:
Title
Proportion of patients having new development or progression of Acute Kidney Injury in both groups
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Number of participants with resolution of Spontaneous Bacterial Peritonitis in both groups
Time Frame
Day 7
Title
Changes in RRI (Renal Resistive Index) in both groups
Time Frame
Day 6
Title
Number of participants who will develop volume overload in both groups
Time Frame
Day 7
Title
Number of participants who will not survive in both groups.
Time Frame
Day 7
Title
Number of participants who will not survive in both groups.
Time Frame
Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>18 years of age
Cirrhosis with SBP (community acquired, health care associated and nosocomial) and baseline serum bilirubin ≥4 mg/dl and/or SCr ≥ 1 mg/dl.
Exclusion Criteria:
Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
Significant cardiac failure, pulmonary disease
Known CKD ( Chronic Kidney Disease)or findings suggestive of organic nephropathy (proteinuria, haematuria, or Abnormal findings on renal USG)
Hepatocellular carcinoma
HIV (Human Immunodeficiency Virus) infection;
GI (Gastrointestinal) bleed within 1 month before the study
Ileus
Grade 3 to 4 hepatic encephalopathy
Other types of infection
Shock
Presence of any potential causes of dehydration (such as diarrhoea or an intense response to diuretic treatment) within one week before the diagnosis of SBP).
Baseline serum bilirubin <4 mg/dl or S. Cr < 1 mg/dl
Serum creatinine level of > 3.0 mg/dl.
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
12. IPD Sharing Statement
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Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.
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