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

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.

Study Overview

• Status: Withdrawn
• Conditions: Ascites; Peritonitis
• Intervention / Treatment: Other: Culture

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 Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient population will include all patients undergoing diagnostic paracentesis comparing standard culture protocol (bedside inoculation of blood culture bottles with ascitic fluid) with an additional culture collected for study arm. Patients will be all comers for diagnostic paracentesis.

Description

Inclusion Criteria:

• Ascites on ultrasound

Exclusion Criteria:

• Consent declined

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group - blood culture bottles; Standard of care group for control - will inoculate all samples in blood culture bottles for ascitic fluid culture	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).
Study group - sample to lab for culture; Study group - will send a sample of ascitic fluid to lab for inoculation in addition to control sample	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth of bacteria on ascitic fluid culture	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.	through study completion, an average of 1 year to complete enrollment of 460 patients

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to positive ascitic fluid culture	Comparing time to positive culture between control and study arm	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Investigators: Principal Investigator: Ricardo Franco Sadud, MD, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2016
• Primary Completion (Actual): August 19, 2018
• Study Completion (Actual): August 19, 2018

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: September 6, 2016
• First Posted (Estimate): September 12, 2016

Study Record Updates

• Last Update Posted (Actual): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Peritoneal Diseases; Intraabdominal Infections; Ascites; Peritonitis
• Other Study ID Numbers: PRO00027101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES