NCT06817408

Brief Summary

This is a prospective, non-randomized study investigating if organ damage and immune changes can be measured by liquid biopsy NGS through advanced analytical methods.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Mar 2025Dec 2026

First Submitted

Initial submission to the registry

January 14, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 25, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.3 years

First QC Date

January 14, 2025

Last Update Submit

March 17, 2026

Conditions

Sepsis

Keywords

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Patient Survival

    Overall survival

    From date of patient enrollment until date of death for any cause or up to 1 year after patient enrollment date, whichever comes first.

Secondary Outcomes (4)

  • ICU Time

    Up to 1 year after patient enrollment date

  • Hospital Stay Duration

    Up to 1 year after patient enrollment date

  • Renal Replacement Therapy

    Up to 1 year after patient enrollment date

  • Ventilator and Vasopressor Free Days

    Up to 1 year after patient enrollment date

Interventions

ObservationOTHER

One additional blood draw in the Emergency Department as part of their standard of care visit.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who've developed a shocked state or clinical concern that are going thru the Emergency Department.

You may qualify if:

  • Patients who've developed a shocked state (Hypotension or Lactate grade \>4) or Clinical Concern

You may not qualify if:

  • \<18 years of age
  • Pregnant Women
  • Nursing women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood plasma, peripheral blood leukocytes, cfDNA

MeSH Terms

Conditions

Sepsis

Interventions

Observation

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Aadel A Chaudhuri, M.D., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Derek E Vanmeter

CONTACT

507-255-4732Vanmeter.Derek@mayo.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Radiation Oncology

Study Record Dates

First Submitted

January 14, 2025

First Posted

February 10, 2025

Study Start

March 25, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 19, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)