Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis
NCT ID: NCT06026267
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
300 participants
INTERVENTIONAL
2023-10-10
2024-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Dose Arm+Standard Medical therapy
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.
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.
Duration of albumin over 24 hours.
Standard Medical Treatment
Standard Medical Treatment
Reduced Dose Albumin+Standard Medical therapy
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.
Standard Medical Treatment
Standard Medical Treatment
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.
Duration of albumin over 24 hours.
Interventions
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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.
Duration of albumin over 24 hours.
Standard Medical Treatment
Standard Medical Treatment
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.
Duration of albumin over 24 hours.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
75 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ILBS-Cirrhosis-59
Identifier Type: -
Identifier Source: org_study_id
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