Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis

Withdrawn

• Conditions: Peritonitis; Ascites
• Interventions: Other: Culture

• Registration Number: NCT02895919
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-08-22
• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Primary Completion: 2018-08-19
• Study Completion: 2018-08-19
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Ascites on ultrasound

Exclusion Criteria

• Consent declined

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Growth of bacteria on ascitic fluid culture	through study completion, an average of 1 year to complete enrollment of 460 patients	Non inferiority of direct inoculation in laboratory as compared to bedside inoculation with blood culture bottles by comparing growth of bacterial growth between both groups, control and study arm.

Secondary Outcome Measures

Name	Time	Method
Time to positive ascitic fluid culture	through study completion, an average of 1 year	Comparing time to positive culture between control and study arm