Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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).
|
Outcome Measures
Primary Outcome Measures
- 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
- Time to positive ascitic fluid culture [through study completion, an average of 1 year]
Comparing time to positive culture between control and study arm
Eligibility Criteria
Criteria
Inclusion Criteria:
- Ascites on ultrasound
Exclusion Criteria:
- Consent declined
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medical College of Wisconsin
Investigators
- Principal Investigator: Ricardo Franco Sadud, MD, Medical College of Wisconsin
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO00027101