RESUMEN
BACKGROUND: With the recent change in the definition (Sepsis-3 Definition) of sepsis and septic shock, an electronic search algorithm was required to identify the cases for data automation. This supervised machine learning method would help screen a large amount of electronic medical records (EMR) for efficient research purposes. AIM: To develop and validate a computable phenotype via supervised machine learning method for retrospectively identifying sepsis and septic shock in critical care patients. METHODS: A supervised machine learning method was developed based on culture orders, Sequential Organ Failure Assessment (SOFA) scores, serum lactate levels and vasopressor use in the intensive care units (ICUs). The computable phenotype was derived from a retrospective analysis of a random cohort of 100 patients admitted to the medical ICU. This was then validated in an independent cohort of 100 patients. We compared the results from computable phenotype to a gold standard by manual review of EMR by 2 blinded reviewers. Disagreement was resolved by a critical care clinician. A SOFA score ≥ 2 during the ICU stay with a culture 72 h before or after the time of admission was identified. Sepsis versions as V1 was defined as blood cultures with SOFA ≥ 2 and Sepsis V2 was defined as any culture with SOFA score ≥ 2. A serum lactate level ≥ 2 mmol/L from 24 h before admission till their stay in the ICU and vasopressor use with Sepsis-1 and-2 were identified as Septic Shock-V1 and-V2 respectively. RESULTS: In the derivation subset of 100 random patients, the final machine learning strategy achieved a sensitivity-specificity of 100% and 84% for Sepsis-1, 100% and 95% for Sepsis-2, 78% and 80% for Septic Shock-1, and 80% and 90% for Septic Shock-2. An overall percent of agreement between two blinded reviewers had a k = 0.86 and 0.90 for Sepsis 2 and Septic shock 2 respectively. In validation of the algorithm through a separate 100 random patient subset, the reported sensitivity and specificity for all 4 diagnoses were 100%-100% each. CONCLUSION: Supervised machine learning for identification of sepsis and septic shock is reliable and an efficient alternative to manual chart review.
RESUMEN
BACKGROUND: Periintubation hypotension is associated with poor outcomes in the critically ill. We aimed to determine if an admixture of ketamine and propofol for emergent endotracheal intubation in critically ill patients was superior to etomidate. Primary endpoint was the change in mean arterial pressure from baseline to 5 minutes postdrug administration. METHODS: Emergent-use, stratified (shock status and unit type), multiunit, randomized, parallel-group superiority clinical trial was conducted at a tertiary academic medical center. Adult medical/surgical and transplant/oncologic intensive care unit patients undergoing emergent intubation were assigned randomly to receive either ketamine/propofol admixture (0.5 mg/kg of ketamine and propofol each) or reduced dose etomidate (0.15 mg/kg) for emergent intubation. RESULTS: One hundred sixty participants were randomized, and 152 (79 ketamine/propofol admixture, 73 etomidate) were included in the intention-to-treat analysis. There was no statistically significant difference in mean arterial pressure change from baseline to 5 minutes postdrug administration (treatment difference [ketamine/propofol admixture-etomidate]: -2.1 mm Hg; 95% confidence interval, -6.9 mm Hg to +2.7 mm Hg; p = 0.385). In addition, no statistically significant difference was demonstrated in the change of mean arterial pressure from baseline at 10 minutes and 15 minutes postdrug administration, no statistical difference in the use of new-onset vasoactive agents or difficulty of intubation between groups. More patients in the etomidate group required non-red blood cell transfusions (16 [22%] vs. 8 [10%], p = 0.046). For patients who had adrenal testing performed, more patients in the etomidate group developed immediate adrenal insufficiency (13 [81%] of 16 vs. 5 [38%] of 13, p = 0.027). Serious adverse events were rare, 2 (3%) (cardiac arrest, hypotension) in ketamine/propofol admixture and 4 (5%) (hypertension, hypotension) in etomidate (p = 0.430). CONCLUSION: In a heterogeneous critically ill population, ketamine/propofol admixture was not superior to a reduced dose of etomidate at preserving per-intubation hemodynamics and appears to be a safe alternative induction agent in the critically ill. LEVEL OF EVIDENCE: Therapeutic/Care Management, level II. TRIAL REGISTRY: ClinicalTrials.gov, NCT02105415, Ketamine/Propofol Admixture "Ketofol" at Induction in the Critically Ill Against Etomidate: KEEP PACE Trial, IRB 13-000506, Trial Registration: March 31, 2014.
