Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients

NCT02327130 | Completed Results DMC

• 1 other identifier: Canary01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 6

Brief 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 (BDV). This study is seeking to determine if the breath delta value of critically ill adults is an early indicator of the onset of infection that may lead to sepsis.

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

• Change in Breath Delta Value

  The variation in breath delta value was assessed regardless of infection status. Exhaled breath samples were collected from participants upon enrollment and every four hours thereafter until the end of the subject's study duration per protocol. Each subject was used as its own control for the purpose of trend analysis.The first breath sample collected was considered an individual's "baseline" sample. The change in the breath delta value was calculated from this baseline sample.

  Baseline to ICU discharge or 7 days, whichever came first

Secondary Outcomes (1)

• Number of Participants With an Infection Diagnosis

  Days 1 through 7

Other Outcomes (1)

• Positive and Negative Predictive Value of BDV for Infection Diagnosis

  7 days

Study Arms (1)

Exhaled Breath

EXPERIMENTAL

Exhaled 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. We will use the Isomark Canary™ to determine the BDV of breath samples collected during this study. Analysis results of these samples will be combined with data that is abstracted from the subjects' medical records.

Device: Isomark Canary™

Interventions

Isomark Canary™ DEVICE

Isomark, LLC is a Madison, Wisconsin-based company that has developed an investigational device, the Isomark Canary™, that is intended to determine the breath delta value of breath samples collected from critically ill patients.

Exhaled Breath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 years or older
• critically ill patient admitted to trauma or surgical ICU
• expected duration of hospital stay at least 120 hours (five days) from time of study enrollment
• subject/LAR speaks a language of which the IRB has approved a consent form

You may not qualify if:

• known infection at the time of enrollment per infection definitions in section 6.2
• known use of systemic antibiotic, antimicrobial and/or antifungal therapy within the last 7 days (See Antibiotic Use section below)
• prolonged antibiotic or antimicrobial use during the perioperative period (See Antibiotic Use section below)
• currently active cancer, or receiving treatment for cancer (including but not limited to: radiation, chemotherapy, systemic orals, etc)
• receiving high frequency ventilatory support
• if not intubated, unable to cooperate with providing a breath sample
• expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family/medical team (e.g., likely to withdraw life support measures within 24 hrs of screening)
• female who is pregnant or lactating (negative serum or urine pregnancy test results within 48 hours of enrollment or to be performed during screening)
• prisoner
• known participation in an interventional research study within 30 days prior to enrollment (note: to be eligible, any interventional treatment must have ended at least 30 days ago)
• Individuals who are directly affiliated with sponsor or study staff, or their immediate families. Immediate family is defined as spouse, domestic partner, parent, child, or sibling whether legally adopted or biological.
• Any patient that is deemed unfit for study participation, per the Investigator's discretion.

Sponsors & Collaborators

• Isomark, LLC: lead
• University of Florida: collaborator
• Ohio State University: collaborator
• Washington University School of Medicine: collaborator
• University of Colorado, Denver: collaborator

Study Sites (6)

University of Florida Health

Gainesville, Florida, 32608, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53706, United States

Location

Isomark, LLC

Madison, Wisconsin, 53711, United States

Location

Related Publications (1)

• O'Rourke AP, Buckman SA, Evans DC, Kerwin AJ, Breunig EA, Butz DE. Changes in exhaled 13CO2/12CO2 breath delta value as an early indicator of infection in intensive care unit patients. J Trauma Acute Care Surg. 2019 Jan;86(1):71-78. doi: 10.1097/TA.0000000000002097.

  PMID: 30575683 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Daniel Butz, Chief Scientific Officer
• Organization: Isomark, LLC

daniel.butz@isomark.com

(608) 561-1895

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 30, 2014
• Study Start: April 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 3, 2019
• Results First Posted: January 3, 2019

Record last verified: 2018-12

Locations

US (6)