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

A Multi-center Randomized Controlled Trial of C-reactive Protein Measurement on Ordering of Blood Cultures in Emergency Department Patients With Sepsis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03714841
Enrollment
208
Registered
2018-10-22
Start date
2017-01-21
Completion date
2021-05-15
Last updated
2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia, Infection, Sepsis

Keywords

C reactive protein, randomized controlled trial, Blood culture

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.

Interventions

OTHERCRP

Knowledge of CRP value

Sponsors

Providence Health & Services
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood culture obtained8 hoursBlood cultures ordered (Yes/No)

Secondary

MeasureTime frameDescription
28 day mortality28 daysPatient died within 28 days
false positive blood culture28 daysfalse positive blood culture (Y/N)
Antibiotic prescribing7 daysnumber of antibiotic prescriptions provided
length of stay28 daysLength of emergency department stay (days)
Admission to hospital7 dayspatient admitted to hospital (yes/No)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026