AscitesNCT02895919
Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis
An observational study of Ascites and Peritonitis, run by Medical College of Wisconsin.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ascites, Peritonitis
- What is being tested?
- Culture
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Aug 2016to 19 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Ascites on ultrasound
Who cannot join
- Consent declined
About this study
Official title: Is Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis Associated With a Higher Sensitivity for Positive Cultures? Prospective Observational Trial
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.
Read the 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.
- Conditions
- Ascites, Peritonitis
- Being tested
- Culture
- Medical subject headings
- Ascites, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CultureOther
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 | Role | What they receive |
|---|---|---|
| Control group - blood culture bottles | Standard of care group for control - will inoculate all samples in blood culture bottles for ascitic fluid culture Receives: 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 Receives: Other: Culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year to complete enrollment of 460 patients
Secondary outcomes (1)
Time to positive ascitic fluid culture
Comparing time to positive culture between control and study arm
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2016 (estimated)
- Study start22 Aug 2016
- Primary completion19 Aug 2018
- Study completion19 Aug 2018
Why it stopped: IRB expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Franco Sadud, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895919
- Sponsor's protocol ID
- PRO00027101
- Status last verified
- Dec 2019
- First submitted
- 31 Aug 2016
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis Associated With a Higher Sensitivity for Positive Cultures? Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT02895919
- Acronym / sponsor ID
- PRO00027101
- Conditions
- Ascites, Peritonitis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: IRB expired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 22 Aug 2016 (actual)
- Primary completion
- 19 Aug 2018 (actual)
- Study completion
- 19 Aug 2018 (actual)
- First posted
- 12 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - blood culture bottles | – | Other: CultureStandard of care group for control - will inoculate all samples in blood culture bottles for ascitic fluid culture |
| Study group - sample to lab for culture | – | Other: CultureStudy group - will send a sample of ascitic fluid to lab for inoculation in addition to control sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Ascites on ultrasound
Key exclusion criteria (1 listed)
- Consent declined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cultureculture of ascitic fluid in standard culture media of blood culture bottles at bedside and fluid collected for culture in laboratory (study arm). | Other | Control group - blood culture bottles, Study group - sample to lab for culture |
Primary outcome
Growth of bacteria on ascitic fluid culture
Time frame: 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.
1 secondary outcome
Time to positive ascitic fluid culture
Time frame: through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Franco Sadud, MD principal investigator
Medical College of Wisconsin
Questions about this trial
What is this clinical trial studying?
An observational study of Ascites and Peritonitis, run by Medical College of Wisconsin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth of bacteria on ascitic fluid culture (time frame: through study completion, an average of 1 year to complete enrollment of 460 patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.