Sepsis Clinical Trial
Official title:
Implementation and Evaluations of Previously Developed Novel Early Warning System to Detect and Treat Sepsis
Verified date | July 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to study the implementation and impact of an early warning system to detect and treat sepsis in the emergency room. We are observing the implementation of a Sepsis Machine Learning Model on all Adult patients. All data (observations field notes, interview recording & transcripts, and survey responses) will be stored on HIPAA-compliant Duke servers behind the Duke firewall, and requiring password-protected user authentication to access. The risk to patients is minimal. The two risks to interviewed clinical staff we have identified involve loss of work time and anonymity.
Status | Completed |
Enrollment | 32003 |
Est. completion date | July 5, 2019 |
Est. primary completion date | July 5, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Arrival to Duke University Hospital emergency department pods A, B, and C, or resuscitation bay Exclusion Criteria: - Under 18 years old at time of emergency department arrival |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Hospital | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | Data & Society Research Institute, Duke Clinical Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of antibiotic orders in Duke University Hospital emergency department per month | Number of antibiotic orders in Duke University Hospital emergency department per month | Within 96 hours of emergency department arrival | |
Other | Number of antibiotic days in Duke University Hospital emergency department per month | Number of antibiotic days | Within 96 hours of emergency department arrival | |
Other | Number of blood culture orders in Duke University Hospital emergency department per month | Total blood culture orders | Within 96 hours of emergency department arrival | |
Other | Number of lactate orders in Duke University Hospital emergency department per month | Total lactate orders | Within 96 hours of emergency department arrival | |
Other | Number of IV fluid orders in Duke University Hospital emergency department per month | Total IV fluid orders | Within 96 hours of emergency department arrival | |
Other | Number of vasopressor orders in Duke University Hospital emergency department per month | Total vasopressor orders | Within 96 hours of emergency department arrival | |
Other | Number of vasopressor days in Duke University Hospital emergency department per month | Number of vasopressor days | Within 96 hours of emergency department arrival | |
Primary | Rate of Centers for Medicare and Medicaid Services (CMS) bundle completion for patients with sepsis | Proportion of patients with sepsis that complete Center for Medicare and Medicaid Services treatment bundle | Within 96 hours of emergency department arrival | |
Secondary | Mean time from ED arrival to sepsis for patients with sepsis | Mean time from to ED arrival to sepsis | Within 96 hours of emergency department arrival | |
Secondary | Average number of patients who develop sepsis per day and month | Number of patients daily who meet sepsis phenotype | Within 96 hours of emergency department arrival | |
Secondary | Average number of patients who develop sepsis and are not treated per day and month | Number of patients daily who meet sepsis phenotype who are not treated for sepsis | Within 96 hours of emergency department arrival | |
Secondary | Mean ED length of stay for patients with sepsis | Emergency department length of stay for patients with sepsis | Within 96 hours of emergency department arrival | |
Secondary | Mean Hospital length of stay for patients with sepsis | Hospital length of stay for patients with sepsis | Within 30 days of emergency department arrival | |
Secondary | Mean Inpatient mortality for patients with sepsis | Inpatient mortality for patients with sepsis | Within 30 days of emergency department arrival | |
Secondary | Mean ICU requirement rate for patients with sepsis | Intensive care unit requirement rate for patients with sepsis | Within 30 days of emergency department arrival | |
Secondary | Mean time from sepsis onset to blood culture | Time of sepsis to blood culture order and collection for patients with sepsis | Within 96 hours of emergency department arrival | |
Secondary | Mean time from sepsis onset to antibiotics | Time of sepsis to antibiotic order and administration for patients with sepsis | Within 96 hours of emergency department arrival | |
Secondary | Mean time from sepsis onset to IV fluids | Time of sepsis to IV fluids order and administration for patients with sepsis | Within 96 hours of emergency department arrival | |
Secondary | Mean time from sepsis onset to lactate | Time of sepsis to lactate collection for patients with sepsis | Within 96 hours of emergency department arrival | |
Secondary | Mean time from sepsis onset to CMS bundle completion | Time of sepsis to CMS bundle completion for patients with sepsis | Within 96 hours of emergency department arrival | |
Secondary | Rate of lactate complete for patients with sepsis | Proportion of lactate drawn within 3 hours and potentially re-drawn within 6 hours of sepsis for patients with sepsis | Within 96 hours of emergency department arrival | |
Secondary | Number of sepsis diagnosis codes across Duke University Hospital patients per month | Number of billing diagnosis codes for sepsis | Within 30 days of emergency department arrival |
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