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Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis

NCT ID: NCT02895919

Last Updated: 2019-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-22

Study Completion Date

2018-08-19

Brief Summary

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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

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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.

Conditions

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Ascites Peritonitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Control group - blood culture bottles

Standard of care group for control - will inoculate all samples in blood culture bottles for ascitic fluid culture

Culture

Intervention Type OTHER

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

Culture

Intervention Type OTHER

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

Interventions

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Culture

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ascites on ultrasound

Exclusion Criteria

* Consent declined
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Franco Sadud, MD

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Other Identifiers

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PRO00027101

Identifier Type: -

Identifier Source: org_study_id