SepsisNCT02327130
Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients
A study testing Isomark Canary™ in people with Sepsis, run by Isomark, LLC at 6 sites in United States.
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 (BDV). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Isomark Canary™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Ohio State University
Columbus, Ohio, 43210
University of Florida Health
Gainesville, Florida, 32608
University of Florida
Jacksonville, Florida, 32209
University of Wisconsin - Madison
Madison, Wisconsin, 53706
Isomark, LLC
Madison, Wisconsin, 53711
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
Read the detailed description
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.
- Conditions
- Sepsis
- Being tested
- Isomark Canary™
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Isomark Canary™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to ICU discharge or 7 days, whichever came first
Secondary outcomes (1)
Number of Participants With an Infection Diagnosis
Daily analysis infection status from blood samples given from each participant.
Measured: Days 1 through 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2014 (estimated)
- Study startApr 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isomark, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florida, Ohio State University, Washington University School of Medicine, University of Colorado, Denver
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02327130
- Sponsor's protocol ID
- Canary01
- Status last verified
- Dec 2018
- First submitted
- 23 Dec 2014
- Last updated
- 3 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30575683
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Exhaled 13CO2/12CO2 Breath Delta Value as an Early Indicator of Infection in ICU Patients
- ClinicalTrials.gov ID
- NCT02327130
- Acronym / sponsor ID
- Canary01
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Isomark, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Florida, Ohio State University, Washington University School of Medicine, University of Colorado, Denver
- Study start
- Apr 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 30 Dec 2014 (estimated)
- Results
- Posted 3 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exhaled Breath | Experimental | Device: Isomark Canary™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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Exhaled Breath |
Primary outcome
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.
1 secondary outcome
Number of Participants With an Infection Diagnosis
Time frame: Days 1 through 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30575683O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isomark Canary™ in people with Sepsis, run by Isomark, LLC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Breath Delta Value (time frame: Baseline to ICU discharge or 7 days, whichever came first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02327130, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.