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OpenTrials
Completed

NCT Number: NCT02756741

Comparison of Standard Dose Versus Once a Day Intravenous Albumin in Spontaneous Bacterial Peritonitis

The standard recommended management of spontaneous bacterial peritonitis (SBP) includes a third-generation cephalosporin (cefotaxime or ceftriaxone) and high dose albumin (1.5g/kg on day 1 and 1g/kg on day 3). The major drawback of the current recommendations is the high price of albumin. In the current randomized control trial investigators compared the effect of standard recommended dose of albumin (1.5g/kg on day 1 and 1g/kg on day 3) vs. low dose (20g/d for 5 days) on the resolution of SBP and subsequent cytokine changes in ascitic fluid and blood.

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Key information

Conditions

Cirrhosis Blood-Borne Infections Cardiovascular Diseases Communicable Diseases DNA Virus Infections Digestive System Diseases Fibrosis Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Varicose Veins Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of SBP
  • Age > 18 years
  • Consent to participate in the trial

Exclusion criteria

  • Secondary peritonitis
  • Malignancies including HCC

Treatment and study plan

ALBUMIN

Drug

Albumin in two different doses

Primary outcomes

  1. Change in neutrophils/mm in ascitic fluid

    Time frame: 3 days

  2. Change in IL-6, IL-1, TNF in ascitic fluid and serum between the two groups

    Time frame: 5 days

Secondary outcomes

  1. Survival in days at the end of therapy

    Time frame: 5 days

  2. Differences in frequency of sepsis, renal failure and other organ failures between the two groups

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences

Other

Registry information

Official study title

Assessment of Cytokine Profile in an Open Labeled Randomized Controlled Trial of Standard Dose vs. Once a Day Intravenous Albumin in Patients With Spontaneous Bacterial Peritonitis

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2016
Registry last updated
Apr 29, 2016

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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