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

NCT ID: NCT03714841

Last Updated: 2020-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-21
• Study Completion Date: 2021-05-15

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.

Conditions

Sepsis; Infection; Bacteremia

Keywords

C reactive protein; randomized controlled trial; Blood culture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

CRP value

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

Group Type: EXPERIMENTAL

CRP

Intervention Type: OTHER

Knowledge of CRP value

CRP value unknown

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

Group Type: ACTIVE_COMPARATOR

CRP

Intervention Type: OTHER

Knowledge of CRP value

Interventions

CRP

Knowledge of CRP value

Intervention Type: OTHER

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Providence Health & Services

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Rob Stenstrom

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Stenstrom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Providence Health & Services

Locations

St Paul's Hospital

Vancouver, British Columbia, Canada

Mount St Joseph's Hospital

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33534419 (View on PubMed)

Other Identifiers

H15-03281

Identifier Type: -

Identifier Source: org_study_id