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OpenTrials
Completed

NCT Number: NCT03497182

Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ventura County Medical Center

Ventura, California, 93003, United States

About this study

Breath samples will be collected from patients suspected of sepsis that meet the criteria in the hospital's Sepsis Patient Management Protocol for blood lactate point of care testing. The breath samples will be collected from the patient by the Respiratory Therapist (RT) at the time of blood sample collection for the blood lactate test.

The breath samples will be analyzed via gas chromatography-surface acoustic wave spectroscopy for detection of a pattern of volatile organic compounds (VOCs). Multivariate analysis will be performed on breath sample data to determine feasibility of associating a unique VOC pattern with septic/severe septic/septic shock patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Breath sample collection

Device

Subject exhales into breath collection container.

Primary outcomes

  1. Volatile Organic Compound (VOC) Pattern

    Time frame: five minutes

    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.

Sponsors and collaborators

Lead sponsor

Landon Pediatric Foundation

Other

Registry information

Official study title

Study to Assess Feasibility of Sepsis, Severe Sepsis and Septic Shock Detection by Breath Analysis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2018
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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