An observational study in Severe Sepsis, Septic Shock and Bacteremia, sponsored by University of British Columbia. Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-16.
Sponsored by University of British Columbia · Observational
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.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's enrollment of 330 is above the median of 160 across 957 observational studies indexed under Sepsis.
Browse Sepsis studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients (age > 18) who present to the emergency department with severe sepsis/septic shock .
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Exclusion Criteria:
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.
The primary outcome is the measure of blood culture positivity before and after antibiotic administration.
Time frame: Four months
Ran from Mar 2014 to primary completion in Sep 2018, 54 months.
Of 408 non-industry observational studies under Sepsis, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's 54 months is above that.
Counting every sponsor, half of 452 studies reached it within 29 months; a quarter within 12 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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