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

NCT04273373 | Completed

• 1 other identifier: ILBS-AKI-03
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients having new development or progression of Acute Kidney Injury in both groups

  Day 7

Secondary Outcomes (5)

• Number of participants with resolution of Spontaneous Bacterial Peritonitis in both groups

  Day 7

• Changes in RRI (Renal Resistive Index) in both groups

  Day 6

• Number of participants who will develop volume overload in both groups

  Day 7

• Number of participants who will not survive in both groups.

  Day 7

• Number of participants who will not survive in both groups.

  Day 28

Study Arms (2)

Standard dose albumin+SOC

ACTIVE COMPARATOR

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

Biological: Standard dose Albumin

Low dose albumin+SOC

EXPERIMENTAL

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

Biological: Low Dose Albumin

Interventions

Low Dose Albumin BIOLOGICAL

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

Low dose albumin+SOC

Standard dose Albumin BIOLOGICAL

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

Standard dose albumin+SOC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

Related Publications (1)

• 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.

  PMID: 37422602 DERIVED

MeSH Terms

Interventions

Albumins

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 18, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

IN (1)