Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis

Study Overview
=================
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.

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

Conditions
-----------------
Ascites, Peritonitis

Intervention / Treatment
-----------------
* Other: Culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ascites on ultrasound Exclusion Criteria: Consent declined

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group - blood culture bottles<br>Standard of care group for control - will inoculate all samples in blood culture bottles for ascitic fluid culture | Other: Culture<br>* culture of ascitic fluid in standard culture media of blood culture bottles at bedside and fluid collected for culture in laboratory (study arm).<br>|
| Study group - sample to lab for culture<br>Study group - will send a sample of ascitic fluid to lab for inoculation in addition to control sample | Other: Culture<br>* culture of ascitic fluid in standard culture media of blood culture bottles at bedside and fluid collected for culture in laboratory (study arm).<br>|

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 |