Predictive Value of Procalcitonin for Bacteremia in the ICU | NCT03497741

Studies
Predictive Value of Procalcitonin for Bacteremia in the ICU

NCT03497741

Sponsor

Rijnstate Hospital

Status

Completed

Last Update Posted

Jun 21, 2024Actual

Enrollment

170Actual

Phase

Not provided

Conditions

Sepsis
Procalcitonin

Interventions

procalcitonin measurement

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Actual

Primary Completion Date

Jan 1, 2019Actual

Completion Date

Mar 1, 2019Actual

First Submitted Date

Mar 28, 2018

First Submission Date that Met QC Criteria

Apr 12, 2018

First Posted Date

Apr 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2024

Last Update Posted Date

Jun 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
procalcitonin measurement	Diagnostic Test	For each patient were blood cultures were taken, a procalcitonin level was determined

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 .	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted to the ICU
Age > 18 years

Exclusion Criteria:

Hemodialysis/ Continuous Veno-Venous Hemofiltration

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients admitted to the ICU whom blood cultures are taken for suspected bacterial infection.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
H.J. van Leeuwen	Rijnstate Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rijnstate hospital		Arnhem	Gelderland		Netherlands

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

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