Right Dose Right Now: bedside data-driven personalized antibiotic dosing in severe sepsis and septic shock - rationale and design of a multicenter randomized controlled superiority trial.
Journal:
Trials
Published Date:
Dec 18, 2019
Abstract
BACKGROUND: Antibiotic exposure is often inadequate in critically ill patients with severe sepsis or septic shock and this is associated with worse outcomes. Despite markedly altered and rapidly changing pharmacokinetics in these patients, guidelines and clinicians continue to rely on standard dosing schemes. To address this challenge, we developed AutoKinetics, a clinical decision support system for antibiotic dosing. By feeding large amounts of electronic health record patient data into pharmacokinetic models, patient-specific predicted future plasma concentrations are displayed graphically. In addition, a tailored dosing advice is provided at the bedside in real time. To evaluate the effect of AutoKinetics on pharmacometric and clinical endpoints, we are conducting the Right Dose Right Now multicenter, randomized controlled, two-arm, parallel-group, non-blinded, superiority trial.
Authors
Keywords
Adult
Anti-Bacterial Agents
Artificial Intelligence
Big Data
Dose-Response Relationship, Drug
Drug Monitoring
Equivalence Trials as Topic
Female
Humans
Intensive Care Units
Kaplan-Meier Estimate
Male
Multicenter Studies as Topic
Netherlands
Randomized Controlled Trials as Topic
Research Design
Severity of Illness Index
Shock, Septic
Treatment Outcome