Assessment for Implementation Methods in Sepsis

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Rhode Island Hospital
Study ID
NCT05491941
Status
Recruiting
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Conditions

  • Sepsis Severe
  • Septic Shock

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sepsis Bundle — OTHER
    Intervention initiated within 1 hour or 3 hours of presentation depending on the Arm: 1. Measure lactate level. 2. Obtain blood cultures before administering antibiotics. 3. Administer broad-spectrum antibiotics. 4. Begin rapid administration of 30ml/kg crystalloid for hypotension or lactate greater than or equal to 4mmol/L. 5. Apply vasopressor if hypotensive during or after fluid resuscitation to maintain a mean arterial pressure greater than or equal to 65 mm Hg.

Study Details

Since the introduction of sepsis bundles, there have been multiple published trials that have demonstrated a consistent, strong association between implementation of sepsis "bundles" (3-hour bundle) and improved survival. The current proposal is a Hybrid 2, pragmatic, cluster randomized clinical effectiveness/implementation trial evaluating mortality and respiratory failure-based outcomes, in patients admitted to the emergency department with sepsis, comparing the effectiveness of implementation of the hour-1 bundle to 3-hour bundle, while facilitating adherence to both bundles. In addition, 4 distinct sepsis phenotypes will be derived from routine clinical data to identify specific patient phenotypes that allow for a more precision-based application of sepsis bundles in future studies.

Key Dates

Start date
Jul 15, 2022
Status verified
Aug 2022
Primary completion
Jul 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
10,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Hour-1 Bundle
    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.
  • Active Comparator: 3-Hour Bundle
    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.

Primary Outcome Measure

Mortality [ Time Frame: 28 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island HospitalProvidenceRhode Island02903
Mitchell Levy, MD
[email protected]
401-444-4000

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