NCT03714841

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P50-P75 for not_applicable sepsis

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable sepsis

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

3.7 years

First QC Date

March 13, 2018

Last Update Submit

November 18, 2020

Conditions

SepsisInfectionBacteremia

Keywords

C reactive proteinrandomized controlled trialBlood culture

Outcome Measures

Primary Outcomes (1)

  • Blood culture obtained

    Blood cultures ordered (Yes/No)

    8 hours

Secondary Outcomes (5)

  • 28 day mortality

    28 days

  • false positive blood culture

    28 days

  • Antibiotic prescribing

    7 days

  • length of stay

    28 days

  • Admission to hospital

    7 days

Study Arms (2)

CRP value

EXPERIMENTAL

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

Other: CRP

CRP value unknown

ACTIVE COMPARATOR

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

Other: CRP

Interventions

CRPOTHER

Knowledge of CRP value

CRP valueCRP value unknown

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Paul's Hospital

Vancouver, British Columbia, V1S1Y1, Canada

Location

Mount St Joseph's Hospital

Vancouver, British Columbia, V5T 3N4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 33534419DERIVED

MeSH Terms

Conditions

SepsisInfectionsBacteremia

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Robert Stenstrom, MD, PhD

    Providence Health & Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 13, 2018

First Posted

October 22, 2018

Study Start

January 21, 2017

Primary Completion

September 15, 2020

Study Completion

May 15, 2021

Last Updated

November 20, 2020

Record last verified: 2020-11

Locations

CA(2)