Code Sepsis protocol (full implementation)
OtherImplementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
NCT Number: NCT04148989
Sepsis is a life-threatening complication of infection that can be difficult to recognize and treat promptly. Timely administration of antibiotics for emergency department (ED) patients with sepsis is challenging. The goal of this study is to determine the potential effectiveness and unintended consequences of reorganizing ED care for patients with suspected sepsis.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Intermountain Medical Center, Murray, Utah, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(overall):
Exclusion criteria
(overall):
(1) Trauma patient
Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
Time frame: Up to 24 hours from ED arrival (an average of 3 hours)
Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation
Time frame: 30 days after ED arrival
Sepsis patient death on or before the 30th day after ED arrival
Time frame: 1 year after ED arrival
Sepsis patient death on or before the 365th day after ED arrival
Time frame: From the time of admission to hospital discharge (up to 1 year, average 14 days)
Sepsis patient death prior to hospital discharge
Time frame: From the time of admission to hospital discharge (up to 1 year, average 14 days)
Amount charged to sepsis patient for their medical care during index ED visit and associated hospitalization
Time frame: From the time of admission to hospital discharge (up to 1 year, average 14 days)
Length of time from sepsis patients' ED arrival until hospital discharge
Time frame: Up to 24 hours from ED arrival (an average of 6 hours)
Fraction of all ED patients receiving antibiotics within 24 hours of ED arrival
Time frame: From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)
Measured as the fraction of sepsis patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics
Time frame: From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)
Measured as the fraction of all ED patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics
Time frame: Beginning 72 hours after ED arrival to 90 days after ED arrival
Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among ED sepsis patients and (2) all ED patients.
Time frame: Beginning 72 hours after ED arrival to 90 days after ED arrival.
Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among all ED patients.
Time frame: Up to 24 hours from ED arrival (an average of 6 hours)
Fraction of ED patients with a primary hospital discharge diagnosis of congestive heart failure or venous thromboembolism and no discharge diagnosis consistent with infection who received antibiotics in the ED
Time frame: Up to 24 hours from ED arrival (an average of 6 hours)
Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum.
Time frame: Up to 24 hours from ED arrival (an average of 6 hours)
Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum.
Intermountain Health Care, Inc.
Other
Acronym: Code Sepsis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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