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Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02895919

Enrollment

Registered

2016-09-12

Start date

2016-08-22

Completion date

2018-08-19

Last updated

2019-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ascites, Peritonitis

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.

Interventions

OTHERCulture

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Ascites on ultrasound

Exclusion criteria

* Consent declined

Design outcomes

Primary

Measure	Time frame	Description
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026