NCT03497182

Brief Summary

Breath samples will be collected from patients suspected of sepsis/severe sepsis or septic shock according to hospital sepsis screening criteria in the Emergency Department.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at below P25 for not_applicable sepsis

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 2, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2018

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

April 6, 2018

Last Update Submit

May 3, 2019

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • Volatile Organic Compound (VOC) Pattern

    Detection of a unique pattern of Volatile Organic Compounds (VOCs) in the breath samples of patients confirmed as having sepsis/severe sepsis/septic shock differentiated from subjects confirmed as not septic.

    five minutes

Study Arms (1)

Breath sample collection

EXPERIMENTAL
Device: Breath sample collection

Interventions

Breath sample collectionDEVICE

Subject exhales into breath collection container.

Breath sample collection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • admitted to Emergency Department
  • suspected of sepsis according to hospital screening criteria; point of care blood lactate test performed
  • age 18 or older

You may not qualify if:

  • member of Vulnerable Patient Population
  • unable to complete Patient Informed Consent process/document

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ventura County Medical Center

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chris Landon

    Director Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2018

First Posted

April 13, 2018

Study Start

May 2, 2017

Primary Completion

October 6, 2018

Study Completion

October 31, 2018

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)