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.
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
culture of ascitic fluid in standard culture media of blood culture bottles at bedside and fluid collected for culture in laboratory (study arm).
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.
Time frame: through study completion, an average of 1 year to complete enrollment of 460 patients
Time to positive ascitic fluid culture
Comparing time to positive culture between control and study arm
Time frame: through study completion, an average of 1 year
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