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Sepsis Bundle for Sepsis (AIMS Trial)

N/A

Recruiting

Led By Mitchell Levy, MD

Research Sponsored by Rhode Island Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a 3-hour sepsis bundle is more effective than an hour-1 sepsis bundle in reducing mortality and respiratory failure. The trial will also identify specific patient phenotypes that allow for a more precision-based application of sepsis bundles.

Who is the study for?

This trial is for adults over 18 who arrive at the emergency department with sepsis within 6 hours of triage. They must meet specific criteria including infection signs, systemic inflammation response, and organ dysfunction. Pregnant women, patients transferred from other hospitals, those receiving end-of-life care within 6 hours of ED admission or previously admitted for the same condition are excluded.

What is being tested?

The study compares two methods of treating sepsis in an emergency setting: a '1-hour bundle' versus a '3-hour bundle'. It aims to see which method is more effective at reducing mortality and respiratory failure. The trial also seeks to identify patient subtypes that respond best to these treatments using data-driven phenotyping.

What are the potential side effects?

While this trial focuses on implementation methods rather than medications, side effects may arise from the procedures included in the sepsis bundles such as antibiotics administration, fluid resuscitation or organ support measures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mortality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Hour-1 BundleActive Control1 Intervention

If the patient meets 2+ SIRS and chief complaint criteria, a second BPA may be triggered, which displays to the provider. The second alert identifies patients who progress to organ failure based on lab results, or who have a recorded instance of hypotension. When this alert appears, an automatic counter will begin and serve as our Sepsis Time Zero. The provider will receive sepsis order sets and guided to the Sepsis Navigator. The navigator will allow them to review relevant patient data, reference sepsis guidelines, and keep tabs on a live-updating sepsis checklist to ensure they complete each element in order and on time. Following identification in the ED, both study arms will receive the same bundle (see below). The only difference will be the timing: For the Hour-1 bundle, all interventions in the bundle must be initiated within 1 hour.

Group II: 3-Hour BundleActive Control1 Intervention

If the patient meets 2+ SIRS and chief complaint criteria, a second BPA may be triggered, which displays to the provider. The second alert identifies patients who progress to organ failure based on lab results, or who have a recorded instance of hypotension. When this alert appears, an automatic counter will begin and serve as our Sepsis Time Zero. The provider will receive sepsis order sets and guided to the Sepsis Navigator. The navigator will allow them to review relevant patient data, reference sepsis guidelines, and keep tabs on a live-updating sepsis checklist to ensure they complete each element in order and on time. Following identification in the ED, both study arms will receive the same bundle (see below). The only difference will be the timing: For the 3-hour bundle, all elements must be completed by 3 hours.

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