CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
Isomark Canary™device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02327130
NCT02327130N/ACompleted
CompareCT.gov

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

Isomark, LLC·interventional·Posted Dec 30, 2014·Updated Jan 3, 2019

In Brief

A clinical study evaluating Isomark Canary™ for Sepsis. Completed, enrolled 32 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesUnited States
CollaboratorsUniversity of Florida, Ohio State University, Washington University School of Medicine, University of Colorado, Denver

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 30, 2014
Enrollment StartApr 1, 2015
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 11.5 years ago

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.