Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02327130|
Recruitment Status : Completed
First Posted : December 30, 2014
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sepsis||Device: Isomark Canary™||Not Applicable|
Sepsis is a major complication for any patient, and its management is an acknowledged challenge for intensivists. Sepsis has unpredictable onset and progression, and is a leading cause of death in ICUs with a mortality rate of 30-50%. Annually in the US, 1.4M cases involve hospitalization, 750,000 cases of severe sepsis or septic shock, and ~260,000 cases of sepsis related death have been reported in recent years. Current experience of UF Health investigators in surgical ICUs is 1 -2 sepsis, severe sepsis, or septic shock patients per day, of which ~10% are trauma patients. Of trauma patients, ~8% develop sepsis during their ICU stay.
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 does not 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.
This study is designed to determine if the BDV of adult ICU patients is an early indicator of the onset of infection that may lead to sepsis.
The objectives of this study are: (1) to measure variation of BDV with time in adult ICU patients who agree to participate as research subjects; (2) to determine the magnitude of change of BDV in subjects who are subsequently diagnosed with severe infection and sepsis; (3) to define variation of BDV in adult trauma subjects who do not develop severe infection.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
Experimental: Exhaled Breath
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™
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.
- Change in Breath Delta Value [ Time Frame: Baseline to ICU discharge or 7 days, whichever came first ]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.
- Number of Participants With an Infection Diagnosis [ Time Frame: Days 1 through 7 ]Daily analysis infection status from blood samples given from each participant.
- Positive and Negative Predictive Value of BDV for Infection Diagnosis [ Time Frame: 7 days ]
Based on an ROC analysis the optimal cutoff value for indicating the presence of infection using the BDV is 1.4‰.
Based on this cutoff value the sensitivity and specificity were calculated. Sensitivity, or the true positive rate, is the proportion of actual positives that are correctly identified. In this case, the sensitivity is the percentage of people who have an infection and were identified by the Isomark Canary as having an 'infection'.
The specificity, or the true negative rate, is the promotion of actual negatives that are correctly identified as negative. In this case, the specificity is the proportion of people without infections that were correctly classified by the Isomark Canary as having 'no infection'.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327130
|United States, Florida|
|University of Florida Health|
|Gainesville, Florida, United States, 32608|
|University of Florida|
|Jacksonville, Florida, United States, 32209|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Wisconsin|
|University of Wisconsin - Madison|
|Madison, Wisconsin, United States, 53706|
|Madison, Wisconsin, United States, 53711|