Predictive Value of Procalcitonin for Bacteremia in the ICU

• Sponsor: Rijnstate Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03497741
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief Summary

Association between plasma procalcitonin levels and positive blood cultures in critical illness patients in the ICU.

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Procalcitonin	Diagnostic Test: procalcitonin measurement

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

• Study Type: Observational
• Anticipated Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Predictive Value of Procalcitonin for Bacteremia in the ICU
• Actual Study Start Date: Oct 1, 2017
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Apr 1, 2019

Outcome Measures

Primary Outcome Measures

1. The predictive value of procalcitonin in blood cultures on the ICU [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 .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients admitted to the ICU

• Age > 18 years

Exclusion Criteria:

• Hemodialysis/ Continuous Veno-Venous Hemofiltration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijnstate hospital	Arnhem	Gelderland	Netherlands

Sponsors and Collaborators

• Rijnstate Hospital

Investigators

• Study Chair: H.J. van Leeuwen, Rijnstate Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rijnstate Hospital
• ClinicalTrials.gov Identifier: NCT03497741
• Other Study ID Numbers: 2016-0877
• First Posted: Apr 13, 2018
• Last Update Posted: Oct 26, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Rijnstate Hospital: Intensive Care Unit
• Additional relevant MeSH terms: Bacteremia

Study Results

No Results Posted as of Oct 26, 2018