Clinical trial NCT03714841: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sepsis
Infection
Bacteremia
Keywords: C reactive protein
randomized controlled trial
Blood culture
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Providence Health & Services
First posted: 2018-10-22
Enrollment: 208
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Blood culture obtained
timeFrame: 8 hours
Secondary outcomes:
measure: 28 day mortality
timeFrame: 28 days
measure: false positive blood culture
timeFrame: 28 days
measure: Antibiotic prescribing
timeFrame: 7 days
measure: length of stay
timeFrame: 28 days
measure: Admission to hospital
timeFrame: 7 days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Mount St Joseph's Hospital
state: British Columbia
Study officials:
affiliation: Providence Health & Services
name: Robert Stenstrom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.