Changes in 13CO2/12CO2 Delta Value in Exhaled Breath as an Early Indicator of Infection in Adult Trauma Subjects

Sepsis Clinical Trial

Official title:

Changes in 13CO2/12CO2 Delta Value in Exhaled Breath as an Early Indicator of Infection in Adult Trauma Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02258022
• Other study ID #: 2014-0294
• Status: Terminated
• Phase: N/A
• First received: September 22, 2014
• Last updated: October 26, 2016
• Start date: October 2014
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Carbon-12 and carbon-13 are naturally-abundant isotopes in exhaled breath carbon dioxide. The ratio of carbon-13 to carbon-12 in exhaled breath is known as the breath delta value. This study is seeking to determine if the breath delta value of adults with trauma is an early indicator of the onset of infection that may lead to sepsis.

Description:

Breath delta value is hypothesized to be a biomarker of infection. Breath delta value is not a defined clinical outcome related to human health, because this study is seeking to establish breath delta value as a biomarker of infection. This study is measuring the feasibility of the Isomark Canary™ device. If the Canary doesn't detect a significant decrease in breath delta value in those subjects who subsequently get an infection, it will not be feasible to use it for this purpose.

Breath delta value will be collected to determine its relationship to infection, no health outcomes are being measured.

In this single-center study of 110 subjects, breath samples will be collected 6 times per day and blood samples will be collected once per day for 7 days. Subjects will be followed for an additional 3 days. Analysis results of these samples will be combined with data that is abstracted from the subjects' medical records. The investigators hypothesize that the measurement of 13C/12C delta value in the exhaled breath of adults is an early indicator of infection in subjects with systemic inflammatory response syndrome secondary to trauma.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 or older

• Admitted to Trauma Service (Surgical patient)

• Expected duration of hospital stay at least 120 hours (5 days) from time of enrollment into study

• Calculated Injury severity score at time of enrollment greater than 15

• Enrolled within 48 hours of arrival to first treating institution (includes emergency department at University of Wisconsin Hospitals and Clinics or outside hospital)

• Subject or surrogate speaks a language for which the institutional review board has approved a consent form

Exclusion Criteria:

• Known infection at the time of enrollment, per Definitions section of the study protocol

• Known antibiotic use in the 7 days prior to admission (note: antibiotic use within the first 48 hours of hospital admission is acceptable)

• Known hemoglobin level less than 6.0 g/dL at any time between arrival to first treating institution and enrollment

• Patient requires high-frequency ventilator strategy

• If not intubated: unable to cooperate with providing a breath sample

• Patients who are pregnant

• Prisoners

• Known participation in another interventional research study within 30 days prior to enrollment (note: to be eligible, any interventional treatment must have ended at least 30 days ago)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Sepsis

Intervention

Device:
• Isomark Canary™
Isomark, LLC is a Madison, Wisconsin-based company that has developed an investigational device, the Isomark Canary™ breath delta value analyzer, that is intended to determine the breath delta value of breath samples collected from critically ill patients. We will use the Isomark Canary™ to determine the breath delta value of breath samples collected during this study.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Breath Delta Value from Baseline to end of Day 1	Ratio of CO2-13 to CO2-12 in exhaled carbon dioxide	At study enrollment, and every 4 hours thereafter for up to 168 hours (7 days from date of enrollment)	No
Primary	Change in Breath Delta Value from end of Day 1 to end of Day 2	Ratio of CO2-13 to CO2-12 in exhaled carbon dioxide	At study enrollment, and every 4 hours thereafter for up to 168 hours (7 days from date of enrollment)	No
Primary	Change in Breath Delta Value from end of Day 2 to end of Day 3	Ratio of CO2-13 to CO2-12 in exhaled carbon dioxide	At study enrollment, and every 4 hours thereafter for up to 168 hours (7 days from date of enrollment)	No
Primary	Change in Breath Delta Value from end of Day 3 to end of Day 4	Ratio of CO2-13 to CO2-12 in exhaled carbon dioxide	At study enrollment, and every 4 hours thereafter for up to 168 hours (7 days from date of enrollment)	No
Primary	Change in Breath Delta Value from end of Day 4 to end of Day 5	Ratio of CO2-13 to CO2-12 in exhaled carbon dioxide	At study enrollment, and every 4 hours thereafter for up to 168 hours (7 days from date of enrollment)	No
Primary	Change in Breath Delta Value from end of Day 5 to end of Day 6	Ratio of CO2-13 to CO2-12 in exhaled carbon dioxide	At study enrollment, and every 4 hours thereafter for up to 168 hours (7 days from date of enrollment)	No
Primary	Change in Breath Delta Value from end of Day 6 to end of Day 7	Ratio of CO2-13 to CO2-12 in exhaled carbon dioxide	At study enrollment, and every 4 hours thereafter for up to 168 hours (7 days from date of enrollment)	No
Secondary	Infection	Analysis of blood samples for procalcitonin and C-reactive protein are biomarkers that are potentially useful in the diagnosis of bacterial sepsis	Days 1, 2, 3, 4, 5, 6, 7	No