From the Research
Overview of the Adaptive Sepsis Trial
- The Adaptive Sepsis trial is not directly mentioned in the provided studies, but information about adaptive clinical trials for sepsis can be found in several studies 1, 2, 3, 4.
- Adaptive clinical trials are designed to evaluate the efficacy of treatments for sepsis, a common syndrome with substantial morbidity and mortality.
Design and Objectives of Adaptive Sepsis Trials
- The VICTAS trial, a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled trial, aimed to determine whether a combination of vitamin C, thiamine, and hydrocortisone increases ventilator- and vasopressor-free days in patients with sepsis 1, 2.
- The SEPSIS-ACT trial, an adaptive phase 2b/3 clinical trial, evaluated the efficacy of selepressin, a novel selective vasopressin V1a receptor agonist, for adults with septic shock 3, 4.
- The primary outcome of these trials was the number of consecutive ventilator- and vasopressor-free days in the first 30 days following randomization.
Key Features of Adaptive Sepsis Trials
- Adaptive sample size design, which allows for interim analyses and adjustments to the sample size based on the response to treatment 1, 2, 3, 4.
- Use of Bayesian algorithms to guide interim decision-making and determine the best dosing regimen for further evaluation 3, 4.
- Response-adaptive randomization, which allows for the allocation of more patients to the most effective treatment arm based on interim results 3, 4.