SepsisNCT03497741
Predictive Value of Procalcitonin for Bacteremia in the ICU
An observational study of Sepsis and Procalcitonin, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Association between plasma procalcitonin levels and positive blood cultures in critical illness patients in the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Procalcitonin
- What is being tested?
- procalcitonin measurement
- How many people
- 170 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2017to 1 Mar 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the ICU whom blood cultures are taken for suspected bacterial infection.
Who may be able to join
- Patients admitted to the ICU
- Age > 18 years
Who cannot join
- Hemodialysis/ Continuous Veno-Venous Hemofiltration
Trial locations and contacts
1 site in 1 country.
About this study
Association between plasma procalcitonin levels and positive blood cultures in critical illness patients in the ICU.
Read the detailed description
Rationale: Association of procalcitonin levels and blood cultures in critical illness patients on the ICU.
Objective: Procalcitonin is an acute phase protein. As part of the acute phase response, procalcitonin is produced during sepsis. Previous research shows that procalcitonin is a biomarker for bloodstream infection. However, there is still little known about the value of procalcitonin in diagnostics for micro-organism underlying a sepsis in ICU patients. In modern practice, blood cultures are taken when a patient is septic to determine the responsible micro-organism. When procalcitonin is a predictive value for bacteremia in the ICU, the number of blood cultures can be reduced.
Study design: An observational cohort study intervention: for each patient in the ICU blood cultures were taken, the procalcitonin level was determined. During 6 months 150 patients will be included.
Main study parameters/endpoints: this study will examine the predictive value of procalcitonin in blood cultures on the ICU.
- Conditions
- Sepsis, Procalcitonin
- Being tested
- procalcitonin measurement
- Keywords
- Intensive Care Unit
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitonin measurementDiagnostic test
For each patient were blood cultures were taken, a procalcitonin level was determined
What is being measured
The primary outcome is the main question the study is designed to answer.
The predictive value of procalcitonin in blood cultures on the ICU
This study will examine the predictive value of procalcitonin on blood cultures on the ICU. A high value of procalcitonin is a predictor for bacteremia.
The predictive value: procalcitonin. Primary outcome: bacteremia .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start1 Oct 2017
- Primary completion1 Jan 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- H.J. van Leeuwen, Study chair, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497741
- Sponsor's protocol ID
- 2016-0877
- Status last verified
- Jun 2024
- First submitted
- 28 Mar 2018
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Procalcitonin for Bacteremia in the ICU
- ClinicalTrials.gov ID
- NCT03497741
- Acronym / sponsor ID
- 2016-0877
- Conditions
- Sepsis, Procalcitonin
- Keywords
- Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 13 Apr 2018 (actual)
- 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.
Association between plasma procalcitonin levels and positive blood cultures in critical illness patients in the ICU.
Detailed description
Rationale: Association of procalcitonin levels and blood cultures in critical illness patients on the ICU.
Objective: Procalcitonin is an acute phase protein. As part of the acute phase response, procalcitonin is produced during sepsis. Previous research shows that procalcitonin is a biomarker for bloodstream infection. However, there is still little known about the value of procalcitonin in diagnostics for micro-organism underlying a sepsis in ICU patients. In modern practice, blood cultures are taken when a patient is septic to determine the responsible micro-organism. When procalcitonin is a predictive value for bacteremia in the ICU, the number of blood cultures can be reduced.
Study design: An observational cohort study intervention: for each patient in the ICU blood cultures were taken, the procalcitonin level was determined. During 6 months 150 patients will be included.
Main study parameters/endpoints: this study will examine the predictive value of procalcitonin in blood cultures on the ICU.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU whom blood cultures are taken for suspected bacterial infection.
Key inclusion criteria (2 listed)
- Patients admitted to the ICU
- Age > 18 years
Key exclusion criteria (1 listed)
- Hemodialysis/ Continuous Veno-Venous Hemofiltration
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 |
|---|---|---|
| procalcitonin measurementFor each patient were blood cultures were taken, a procalcitonin level was determined | Diagnostic test | – |
Primary outcome
The predictive value of procalcitonin in blood cultures on the ICU
Time frame: 6 months
This study will examine the predictive value of procalcitonin on blood cultures on the ICU. A high value of procalcitonin is a predictor for bacteremia. The predictive value: procalcitonin. Primary outcome: bacteremia .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
H.J. van Leeuwen study chair
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Procalcitonin, run by Rijnstate Hospital at 1 site in Netherlands.
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 2 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: finished, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The predictive value of procalcitonin in blood cultures on the ICU (time frame: 6 months). 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 21 Jun 2024.