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NCT Number: NCT04273373

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

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

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Key information

Conditions

Spontaneous Bacterial Peritonitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver and Biliary Sciences

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low Dose Albumin

Biological

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

Standard dose Albumin

Biological

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

Primary outcomes

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

    Time frame: Day 7

Secondary outcomes

  1. Number of participants with resolution of Spontaneous Bacterial Peritonitis in both groups

    Time frame: Day 7

  2. Changes in RRI (Renal Resistive Index) in both groups

    Time frame: Day 6

  3. Number of participants who will develop volume overload in both groups

    Time frame: Day 7

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

    Time frame: Day 7

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

    Time frame: Day 28

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

A Randomized Non-inferiority Trial Comparing Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2020
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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