Sepsis, Septic Shock · Observational Study

Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry record for a planned multicenter observational study validating an IL-6 concentration cutoff to predict 28-day mortality in ICU patients with sepsis or septic shock. No results have been posted to the registry; the record describes enrollment (estimated 700 participants), study type (observational), and primary outcome (28-day all-cause mortality) only.

What was studied

Observational. Sepsis, Septic Shock; age from 22 Years. Intervention: IL-6 concentration measurement at baseline (assay platform and timing not specified in registry record).. n = 700. 5 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a clinical trial registry record describing an active observational study with no reported results; it documents planned enrollment and outcome measures only.

Study design

As stated by the source record.

MethodsCase Only model. Prospective time perspective. Primary outcome measure: 28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days (assessed at Within 28 days after inclusion)

DesignObservational

PopulationSepsis, Septic Shock; age from 22 Years

Sample size700

InterventionIL-6 concentration measurement at baseline (assay platform and timing not specified in registry record).

Setting5 sites: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment700

Primary outcome measure28-day all-cause mortality

Follow-up duration28 days after inclusion

Caveats

This is a registry record only; no results have been reported or analysed.
Study methods (inclusion/exclusion criteria, IL-6 assay platform, cutoff derivation method) are not detailed in the registry text.
Recruitment status is listed as ACTIVE_NOT_RECRUITING; actual enrollment numbers and follow-up completion are not provided.
No comparative data, effect sizes, hazard ratios, or statistical significance are available.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational design with prospective 28-day follow-up; no randomization or control arm.

Directness

strong

Hard endpoint (28-day all-cause mortality) in ICU sepsis population directly relevant to clinical decision-making.

Consistency

insufficient

Registry record alone; no results reported, comparison to prior IL-6 cutoff studies unavailable.

Risk of bias

insufficient

No methods detail provided in registry record; blinding, loss to follow-up, and adjudication not described.

Sample adequacy

moderate

Estimated 700 participants adequate for cutoff validation; actual enrollment and completion not yet reported.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06654895). This is a study registration, not published results. Lead sponsor: Bluejay Diagnostics, Inc.. Recruitment status: ACTIVE_NOT_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 700 participants (ESTIMATED). Conditions: Sepsis, Septic Shock. Primary outcome measures: 28-day all-cause mortality [Time Frame: within 28 days after inclusion] participants will be followed up for 28 days , Within 28 days after inclusion. Brief summary: The primary objective of this study is to validate a pre-defined IL-6 concentration cutoff that predicts 28-day mortality in patients who are admitted or are intended to be admitted to the ICU diagnosed with sepsis or septic shock.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Bluejay DiagnosticsNCT06654895Sepsis, Septic Shock