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

Completed · Not applicable

Conditions studied: Sepsis

In brief

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.

Key facts

Study ID

NCT02327130

Run by

Isomark, LLC

People needed

32

Starts

2015-04-01

Expected to finish

2017-12-01

Last updated by the study team

2019-01-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Florida Health — Gainesville, Florida, United States
• University of Florida — Jacksonville, Florida, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• The Ohio State University — Columbus, Ohio, United States
• University of Wisconsin - Madison — Madison, Wisconsin, United States
• Isomark, LLC — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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