Antibiotic Administration and Blood Culture Positivity in Severe Sepsis and Septic Shock
|ClinicalTrials.gov Identifier: NCT01867905|
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : April 16, 2019
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|
|Study Type :||Observational|
|Actual Enrollment :||330 participants|
|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|
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867905
|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|
|Vancouver, British Columbia, Canada, V6Z 1Y6|
|Montreal General Hospital|
|Montreal, Quebec, Canada, H3G 1A4|
|Royal Victoria Hospital|
|Montreal, Quebec, Canada, H4A 3J1|
|Principal Investigator:||David Sweet, M.D.||University of British Columbia|