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AIMS Study

The Assessment of Implementation of Methods in Sepsis and Respiratory Failure (AIMS) study seeks to determine the safest, most effective approach to sepsis intervention.

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The Assessment of Implementation of Methods in Sepsis and Respiratory Failure (AIMS) study seeks to determine the safest and most effective approach to sepsis intervention using the Surviving Sepsis Campaign guidelines. The five-year prospective multicenter study is being funded by a $3.2 million grant from the National Heart, Lung, and Blood Institute (NHLBI). The Society of Critical Care Medicine (SCCM) will serve as the data and clinical coordinating center for the study.

The goal of the AIMS study is to determine whether the Hour-1 Bundle or 3-Hour Bundle developed by the Surviving Sepsis Campaign is most effective when implemented by emergency departments. The study will be conducted at 18 centers comprising both community and academic hospitals. It will ultimately include about 10,000 patients who will be randomized to receive either the Hour-1 or 3-Hour Bundle.

The implementation of the 3-Hour Bundle is mandated by the Centers for Medicaid and Medicare (CMS). Its steps should be completed within three hours. The steps of the 1-Hour bundle should at least be started within the first hour. In the AIMS study, the bundles will be compared head to head for the first time to verify whether the CMS mandate is the better approach to sepsis intervention.

The National Institutes of Health (NIH) funding is a T3 translational research grant, which seeks to ensure that evidence-based preventative interventions and treatments are delivered effectively. Staff in both the Hour-1 and 3-Hour arms will be trained in techniques for enhancing implementation of either bundle.

The study’s primary outcome is hospital mortality. Secondary outcomes include:
  • Respiratory failure
  • Need for mechanical ventilation
  • Hospital length of study
  • Discharge status (e.g., to home, rehabilitation, or skilled nursing facility)
  • Which bundle is most appropriate for various phenotypes
Mitchell M. Levy, MD, MCCM
Principal Investigator
Mitchell M. Levy, MD, MCCM
Professor of Medicine
System-wide Director, Critical Care, Lifespan Systems
Rhode Island Hospital
Providence, Rhode Island
Project Manager: Lori Harmon, RRT, MBA, CPHQ
Data Managers: Karen Boman and Humera Moulvi
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