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C-reactive Protein Information and Blood Cultures for Emergency Department Patients With Sepsis

Primary Purpose

Sepsis, Infection, Bacteremia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CRP
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring C reactive protein, randomized controlled trial, Blood culture

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Emergency department patients with sepsis: Known or presumed infection and 2 or more SIRS criteria: heart rate > 90/minute; respiratory rate > 20/minute; Oral temperature ≥ 38◦ C or < 36◦ C; white blood cell count > 12,000 or < 4,000.
  • Able to read and understand consent form in English
  • Age 19 years or greater

Exclusion Criteria:

  • Patients presenting with septic shock (systolic blood pressure < 90 mmHG)
  • Patients at risk for endocarditis (previous episodes of endocarditis, injection drug use)
  • Imuno-compromised patients: HIV positive and not on anti-retrovirals; active chemotherapy ; known immune disorder; on immune system modulating drugs, including corticosteroids.
  • indwelling venous catheter (dialysis line, Hickman catheter)
  • hospitalization in previous 2 weeks
  • Surgical procedure in previous 2 weeks

Sites / Locations

  • St Paul's Hospital
  • Mount St Joseph's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CRP value

CRP value unknown

Arm Description

The patients point of care CRP value is known by the treating physician

The patients point of care CRP value is not known by the treating physician

Outcomes

Primary Outcome Measures

Blood culture obtained
Blood cultures ordered (Yes/No)

Secondary Outcome Measures

28 day mortality
Patient died within 28 days
false positive blood culture
false positive blood culture (Y/N)
Antibiotic prescribing
number of antibiotic prescriptions provided
length of stay
Length of emergency department stay (days)
Admission to hospital
patient admitted to hospital (yes/No)

Full Information

First Posted
March 13, 2018
Last Updated
November 18, 2020
Sponsor
University of British Columbia
Collaborators
Providence Health & Services
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1. Study Identification

Unique Protocol Identification Number
NCT03714841
Brief Title
C-reactive Protein Information and Blood Cultures for Emergency Department Patients With Sepsis
Official Title
A Multi-center Randomized Controlled Trial of C-reactive Protein Measurement on Ordering of Blood Cultures in Emergency Department Patients With Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 21, 2017 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
May 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
Collaborators
Providence Health & Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with sepsis (2 or more systemic inflammatory response syndrome criteria and suspected infection) assessed in the emergency department have blood cultures obtained to identify potential blood stream infections (BSI). Blood cultures are expensive, sometimes inaccurate, and only positive about 10% of the time in the emergency department. This study evaluates the effect of physician knowledge of C-reactive protein (CRP) levels on ordering rates of blood cultures in emergency department patients with sepsis. All patients with sepsis will have CRP levels measured using a point-of-care device, prior to blood tests being ordered. Half of participants will have their CRP level available to the emergency physician and half will not. Blood culture ordering rate and safety outcomes will be compared between these two groups.
Detailed Description
Sepsis, which is defined as the presence of a systemic inflammatory response syndrome (SIRS) in conjunction with a suspected or proven infection, is a significant cause of morbidity and mortality. It is an extremely common presentation in emergency departments. Most sepsis protocols and guidelines call for blood cultures to be obtained in patients with sepsis, in order to identify blood stream infections (BSI) which are usually caused by bacteria in the blood. Blood cultures obtained in the emergency department are costly, subject to false positive results, and only positive about 10% of the time. Also, they rarely change patient management. C-reactive protein (CRP) is an inflammatory marker that rises rapidly in the presence of bacterial infections. Because CRP rises as much as 100 times normal levels in the presence of bacterial infections, we have used it successfully to identify patients with sepsis who do not require a blood blood culture, we believe that physicians knowledge of CRP levels can help to guide their decision to order blood cultures.Patients with sepsis (2 or more SIRS criteria and presumed infection) will have their CRP levels measured using a point of care device (Alere Afinion AS100 Analyzer) prior to blood tests being ordered. Patients will be randomized to either have their CRP value shown to the attending physician or not. Rates of blood culture ordering and safety outcomes will then be compared between the two groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Infection, Bacteremia
Keywords
C reactive protein, randomized controlled trial, Blood culture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CRP value
Arm Type
Experimental
Arm Description
The patients point of care CRP value is known by the treating physician
Arm Title
CRP value unknown
Arm Type
Active Comparator
Arm Description
The patients point of care CRP value is not known by the treating physician
Intervention Type
Other
Intervention Name(s)
CRP
Intervention Description
Knowledge of CRP value
Primary Outcome Measure Information:
Title
Blood culture obtained
Description
Blood cultures ordered (Yes/No)
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
28 day mortality
Description
Patient died within 28 days
Time Frame
28 days
Title
false positive blood culture
Description
false positive blood culture (Y/N)
Time Frame
28 days
Title
Antibiotic prescribing
Description
number of antibiotic prescriptions provided
Time Frame
7 days
Title
length of stay
Description
Length of emergency department stay (days)
Time Frame
28 days
Title
Admission to hospital
Description
patient admitted to hospital (yes/No)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Emergency department patients with sepsis: Known or presumed infection and 2 or more SIRS criteria: heart rate > 90/minute; respiratory rate > 20/minute; Oral temperature ≥ 38◦ C or < 36◦ C; white blood cell count > 12,000 or < 4,000. Able to read and understand consent form in English Age 19 years or greater Exclusion Criteria: Patients presenting with septic shock (systolic blood pressure < 90 mmHG) Patients at risk for endocarditis (previous episodes of endocarditis, injection drug use) Imuno-compromised patients: HIV positive and not on anti-retrovirals; active chemotherapy ; known immune disorder; on immune system modulating drugs, including corticosteroids. indwelling venous catheter (dialysis line, Hickman catheter) hospitalization in previous 2 weeks Surgical procedure in previous 2 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Stenstrom, MD, PhD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V1S1Y1
Country
Canada
Facility Name
Mount St Joseph's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5T 3N4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
33534419
Citation
Kyriazopoulou E, Poulakou G, Giamarellos-Bourboulis EJ. Biomarkers in sepsis: can they help improve patient outcome? Curr Opin Infect Dis. 2021 Apr 1;34(2):126-134. doi: 10.1097/QCO.0000000000000707.
Results Reference
derived

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C-reactive Protein Information and Blood Cultures for Emergency Department Patients With Sepsis

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