NCT02895919

Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis

Is Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis Associated With a Higher Sensitivity for Positive Cultures? Prospective Observational Trial

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ascites
• Peritonitis

Interventions

Type	Name	Description
OTHER	Culture	culture of ascitic fluid in standard culture media of blood culture bottles at bedside and fluid collected for culture in laboratory (study arm).

Timeline

• Start date: 2016-08-22
• Primary completion: 2018-08-19
• Completion: 2018-08-19
• First posted: 2016-09-12
• Last updated: 2019-12-11