Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis

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Medical College of Wisconsin

Status

Withdrawn

Conditions

Peritonitis
Ascites

Treatments

Other: Culture

Study type

Observational

Funder types

Other

Identifiers

NCT02895919
PRO00027101

Details and patient eligibility

About

This study seeks to determine non inferiority of direct inoculation of ascitic fluid in lab as compared to current culture media standard, bedside inoculation with blood culture bottles.

Full description

The purpose of this study is to validate the principal study that recommends inoculation with blood culture bottles at bedside versus lab inoculation (delayed inoculation) of ascitic fluid in the diagnosis of spontaneous bacterial peritonitis. This study had a small sample size (29) and goal is to validate results with a larger sample size. The aim of current proposed study is to assess for non inferiority of lab inoculation of ascitic fluid culture versus current standard of blood culture bottles. To achieve 90% power and true sensitivity 95%, goal is to enroll 460 patients within the course of a year or until number of samples is reached, with plan to compare the sensitivity of bedside inoculation of blood culture bottles versus the lab using sterile plate techniques as per current lab culture technique. Unlike previous study, all comers for ascitic fluid collected will be analyzed that are to undergo diagnostic paracentesis.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Ascites on ultrasound

Exclusion criteria

  • Consent declined

Trial design

0 participants in 2 patient groups

Control group - blood culture bottles
Description:
Standard of care group for control - will inoculate all samples in blood culture bottles for ascitic fluid culture
Treatment:
Other: Culture
Study group - sample to lab for culture
Description:
Study group - will send a sample of ascitic fluid to lab for inoculation in addition to control sample
Treatment:
Other: Culture

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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