Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.

NCT ID: NCT04273373

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2020-12-31

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

Conditions

Spontaneous Bacterial Peritonitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard dose albumin+SOC

20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours. SOC (Standard of Care)

Group Type: ACTIVE_COMPARATOR

Standard dose Albumin

Intervention Type: BIOLOGICAL

20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours (duration of infusion 6 hours).

Low dose albumin+SOC

20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg. after 48 hours SOC (Standard of Care)

Group Type: EXPERIMENTAL

Low Dose Albumin

Intervention Type: BIOLOGICAL

20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours

Interventions

Low Dose Albumin

20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours

Intervention Type: BIOLOGICAL

Standard dose Albumin

20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 hours (duration of infusion 6 hours).

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. >18 years of age

2. 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

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 ( Chronic Kidney Disease)or findings suggestive of organic nephropathy (proteinuria, haematuria, or Abnormal findings on renal USG)

4. Hepatocellular carcinoma

5. HIV (Human Immunodeficiency Virus) infection;

6. GI (Gastrointestinal) bleed within 1 month before the study

7. Ileus

8. Grade 3 to 4 hepatic encephalopathy

9. Other types of infection

10. Shock

11. 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).

12. Baseline serum bilirubin <4 mg/dl or S. Cr < 1 mg/dl

13. Serum creatinine level of > 3.0 mg/dl.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

References

Kar PS, Venishetty S, Laroia ST, Jindal A, Maiwall R, Sood AK, Shasthry SM, Rajan V, Arora V, Bhardwaj A, Kumar G, Kumar M. Tolerance of standard dose albumin infused over 6 hrs for treatment of spontaneous bacterial peritonitis-A randomized controlled trial. Indian J Gastroenterol. 2023 Aug;42(4):505-516. doi: 10.1007/s12664-023-01389-x. Epub 2023 Jul 8.

Reference Type: DERIVED

PMID: 37422602 (View on PubMed)

Other Identifiers

ILBS-AKI-03

Identifier Type: -

Identifier Source: org_study_id