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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
AIMS Trial 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.Check my eligibility
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.See study design
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.
AIMS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mortality
AIMS 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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Who is running the clinical trial?
Rhode Island HospitalLead Sponsor
260 Previous Clinical Trials
57,007 Total Patients Enrolled
2 Trials studying Sepsis
179 Patients Enrolled for Sepsis
Mitchell Levy, MDPrincipal InvestigatorRhode Island Hospital
3 Previous Clinical Trials
179 Total Patients Enrolled
3 Trials studying Sepsis
179 Patients Enrolled for Sepsis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I was placed on comfort care within 6 hours of being admitted to the emergency department.I was diagnosed with sepsis within 6 hours of arriving at the emergency department.
Research Study Groups:
This trial has the following groups:- Group 1: Hour-1 Bundle
- Group 2: 3-Hour Bundle
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are accepted for this research endeavor?
"Affirmative, according to clinicaltrials.gov the trial posted on July 15th 2022 is actively enrolling participants. The information was last updated on August 4th and 10 000 individuals are needed at one facility."
Answered by AI
Is participation in this experiment open to volunteers at present?
"According to official records, this clinical trial is actively recruiting participants. Its launch date was July 15th 2022 and it underwent its most recent update on August 4th of the same year."
Answered by AI
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