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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: Recruiting NA study of Septic Shock and Sepsis, Severe, sponsored by Rhode Island Hospital.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Mortality associated with death from sepsis.

Interventions

  • OTHER Sepsis Bundle

Study Locations (1)

Rhode Island

  • Rhode Island Hospital - Providence

Trial Details

FieldValue
Enrollment Target 10,000 participants
Start Date 2022-07-15
Est. Completion 2027-07-15
Phase NA
Rhode Island Hospital

130 total trials

What NCT05491941 shows while recruiting

NCT05491941 is an interventional study that assigns participants to a tested intervention. Its 10,000 participants enrollment target places it among the larger protocols in the corpus, above the 4,642-participant average among 24 other Septic Shock trials with a reported enrollment target (115% higher).

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 a single indexed study location in 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.

Similar trials for Septic Shock

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05491941's enrollment target sits among peer trials

10,000 3rd of 24 higher than 22 of 24 other Septic Shock trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Septic Shock trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05491941, the US trial registry maintained by the National Library of Medicine. NCT05491941 (large enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.