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Trial record 1 of 1 for:    NCT01867905
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Antibiotic Administration and Blood Culture Positivity in Severe Sepsis and Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01867905
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : April 16, 2019
McGill University
University of Arizona
Information provided by (Responsible Party):
Matthew Pellan Cheng, University of British Columbia

Brief Summary:

Sepsis is a significant cause health care expenditure and carries an extremely high rate of morbidity and mortality if not treated appropriately. From 1979 to 2000, sepsis resulted in over 10 million admissions to hospital in the United States with a mortality rate of 17.9 to 27.8 percent. In Canada, it is estimated that the incidence of sepsis from 2008-2009 was 103.3 per 100,000 per year.

Advances in the multifaceted management of sepsis in recent years have resulted in improved clinical outcomes. However, the cornerstone of sepsis management relies on the prompt administration of appropriate antibiotics. Current clinical practice suggests that antibiotic administration can be delayed up to 45 minutes in order to obtain blood cultures, whose results have a profound impact on the type and duration of antimicrobial therapy. Unfortunately, this recommendation is based on very little evidence and the investigators have found that potential life-saving treatment is often delayed in order to abide by it. Furthermore, recent data suggest that mortality could be increased by approximately 5% by delaying antibiotic administration for that time period.

The investigators therefore wish to organize a prospective, multi-centre trial in order to identify the effect of antibiotic administration on blood culture positivity in patients presenting with severe sepsis or septic shock. Other objectives will be to elucidate which patient factors, including age, co-morbid conditions and clinical presentation, as well as antibiotic choice will affect blood culture results.

This study will be conducted in the emergency departments at St. Paul's Hospital (SPH), Vancouver General Hospital (VGH), Lion's Gate Hospital (LGH), Surrey Memorial Hospital, Montreal General Hospital (MGH), Royal Victoria Hospital (RVH) and Maricopa Integrated Health System. Patients identified for the aforementioned conditions will be treated as per routine hospital protocol. If the patient is deemed eligible for the study, a second set of blood of blood cultures will subsequently be drawn ideally between 30 and 60 minutes after the administration of antibiotic therapy. Subject demographic data will be collected pertaining to age, comorbid immunocompromised conditions, vital signs, laboratory tests pertaining to end organ dysfunction, suspected source of sepsis, the type antibiotics administered and the timing of antimicrobial administration with respect to the second set of blood cultures taken.

Our hypothesis is that blood culture positivity in patients presenting with severe sepsis and septic shock will not be altered significantly by antibiotic therapy. If so, our study would strongly argue against delaying life-saving therapy and would thus greatly improve patient care in our local emergency rooms. If incorrect, our study would be the first to demonstrate the benefit of obtaining blood cultures before antibiotic therapy and would strengthen current recommendations.

Condition or disease
Severe Sepsis Septic Shock Bacteremia

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Study Type : Observational
Actual Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Antibiotic Administration on Blood Culture Positivity in Patients With Severe Sepsis and Septic Shock: a Prospective Multicenter Observational Trial.
Actual Study Start Date : March 1, 2014
Actual Primary Completion Date : September 5, 2018
Actual Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

Severe sepsis and septic shock
Patients who present in severe sepsis or septic shock will have blood cultures taken before and after antibiotic administration. The antibiotic choice will be determined by the emergency physician and the patients will be treated as per routine hospital protocol. No therapeutic interventions will be administered.

Primary Outcome Measures :
  1. The effect of antibiotic administration on blood culture positivity in patients with severe sepsis and septic shock: a prospective multicenter observational trial. [ Time Frame: Four months ]
    The primary outcome is the measure of blood culture positivity before and after antibiotic administration.

Biospecimen Retention:   Samples With DNA
Blood cultures

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients (age > 18) who present to the emergency department with severe sepsis/septic shock .

Inclusion Criteria:

  • Patients greater than 18 years of age who present to the emergency department with the diagnosis of severe sepsis/septic shock.
  • This will include patients that have 2/4 systemic inflammatory response syndrome criteria, a suspected infection and either a initial serum lactate > 4mmol/L or a initial systolic blood pressure < 90 millimeters of mercury.

Exclusion Criteria:

  • Patients in whom antibiotics have been administered >2 hours prior to assessment.
  • Patients with antibiotics in the community in the past 48 hours
  • Patients with known severe coagulopathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01867905

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United States, Arizona
Maricopa Integrated Health Center
Phoenix, Arizona, United States, 85008
Canada, British Columbia
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3V 1Z2
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Saint-Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Royal Victoria Hospital
Montreal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
University of British Columbia
McGill University
University of Arizona
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Principal Investigator: David Sweet, M.D. University of British Columbia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Matthew Pellan Cheng, Medical Resident, University of British Columbia Identifier: NCT01867905    
Other Study ID Numbers: H12-01716
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Keywords provided by Matthew Pellan Cheng, University of British Columbia:
Severe sepsis
Septic shock
Blood culture positivity
Additional relevant MeSH terms:
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Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes
Bacterial Infections