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NCT05491941 · ClinicalTrials.gov registry record · NA
Assessment for Implementation Methods in Sepsis
A NA study of Septic Shock and Sepsis, Severe, sponsored by Rhode Island Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 10,000
- Enrollment target
- 1
- Study location
NCT05491941 is a NA study of Septic Shock and Sepsis, Severe that is actively recruiting participants, run by Rhode Island Hospital. The registered enrollment target is 10,000 participants, above the 4,642-participant average among 24 other Septic Shock trials with a reported enrollment target (115% higher). The trial reports 1 study location across 1 state.
The verdict
NCT05491941, a NA study of Septic Shock and Sepsis, Severe, is actively recruiting participants, sponsored by Rhode Island Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 10,000 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- OTHER Sepsis Bundle
Study Locations (1)
Rhode Island
- Rhode Island Hospital - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,000 participants |
| Start Date | 2022-07-15 |
| Est. Completion | 2027-07-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05491941
The ClinicalTrials.gov registry entry for NCT05491941 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 4,642-participant average among 24 other Septic Shock trials with a reported enrollment target (115% higher). The listed sponsor is Rhode Island Hospital, which has 130 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Septic Shock appearing as the primary indexed condition, and to 1 intervention - of which Sepsis Bundle is the first listed.
NCT05491941 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT05491941 about?
NCT05491941 is a clinical study titled "Assessment for Implementation Methods in Sepsis". 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 eff...
What is the current status of trial NCT05491941?
This trial is currently recruiting. It is a NA study. The enrollment target is 10,000 participants. The study started on 2022-07-15. Estimated completion is 2027-07-15.
What conditions does trial NCT05491941 study?
This clinical trial studies the following conditions: Septic Shock, Sepsis, Severe.
What interventions are being tested in trial NCT05491941?
The interventions under investigation include: Sepsis Bundle (OTHER).
Who is sponsoring clinical trial NCT05491941?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05491941 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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