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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03714841
• Other study ID #: H15-03281
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 21, 2017
• Est. completion date: May 15, 2021

Study information

• Verified date: November 2020
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 208
• Est. completion date: May 15, 2021
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Emergencies
• Infection
• Sepsis
• Toxemia

Intervention

Other:
• CRP
Knowledge of CRP value

Locations

Country	Name	City	State
Canada	Mount St Joseph's Hospital	Vancouver	British Columbia
Canada	St Paul's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Providence Health & Services

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood culture obtained	Blood cultures ordered (Yes/No)	8 hours
Secondary	28 day mortality	Patient died within 28 days	28 days
Secondary	false positive blood culture	false positive blood culture (Y/N)	28 days
Secondary	Antibiotic prescribing	number of antibiotic prescriptions provided	7 days
Secondary	length of stay	Length of emergency department stay (days)	28 days
Secondary	Admission to hospital	patient admitted to hospital (yes/No)	7 days