Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis

NCT02895919 | Withdrawn DMC

• 1 other identifier: PRO00027101
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ascites; Peritonitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to positive ascitic fluid culture

  through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

Culture OTHER

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

Control group - blood culture bottles; Study group - sample to lab for culture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient population will include all patients undergoing diagnostic paracentesis comparing standard culture protocol (bedside inoculation of blood culture bottles with ascitic fluid) with an additional culture collected for study arm. Patients will be all comers for diagnostic paracentesis.

You may qualify if:

• Ascites on ultrasound

You may not qualify if:

• Consent declined

Sponsors & Collaborators

• Medical College of Wisconsin: lead

MeSH Terms

Conditions

Ascites; Peritonitis

Interventions

Culture Techniques

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques

Study Officials

• Ricardo Franco Sadud, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 12, 2016
• Study Start: August 22, 2016
• Primary Completion: August 19, 2018
• Study Completion: August 19, 2018
• Last Updated: December 11, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share