InfectionPhase 1O2BNCT02563678
Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines
A Phase 1 study testing Hyperbaric Oxygen, Hyperbaric Air/Oxygen and Normobaric oxygen in people with Infection, run by Intermountain Health Care, Inc. at 2 sites in United States.
Trial summary
In this small pilot study, participants (patients and healthy volunteers) will have blood drawn before and after the study intervention (hyperbaric chamber session or normal pressure oxygen breathing. This blood will be analyzed for neutrophil oxidative burst and cytokine analysis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- Hyperbaric Oxygen, Hyperbaric Air/Oxygen and Normobaric oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2015to Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include diabetic lower extremity wounds or refractory osteomyelitis)
- Diabetes mellitus
- Current antibiotic use for active infection
- Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include crush injury, acute peripheral arterial insufficiency, or radiation necrosis)
- Adult patients (ages 18-65) admitted to the intensive care unit for acute, life-threatening infection where hyperbaric oxygen is clinically indicated for at least 4 sessions (possible indications include gas gangrene or necrotizing fasciitis)
- Adult patients (ages 18-65) presenting for hyperbaric oxygen for acute carbon monoxide poisoning (up to 3 sessions)
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- Co-enrollment in glucose tolerance testing study
- Meet inclusion/exclusion profile for that study
- Co-enrollment in brain injury study
- Meet inclusion/exclusion profile for that study
- Employees (ages 18-65) medically cleared to work as hyperbaric chamber inside attendants, reporting for a regular duty day
- Healthy volunteers (ages 18-65)
- Medical clearance for hyperbaric oxygen exposure
- Healthy volunteers (ages 18-65)
Who cannot join
- Prior treatment with hyperbaric oxygen within the last 30 days
- Consistent vitamin C or vitamin E supplementation in the past year
- Active tobacco use
- Pregnancy
- Cohort 2: Hyperbaric patients without diabetes or active infection
- Prior treatment with hyperbaric oxygen within the last 30 days
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- Consistent vitamin C or vitamin E supplementation in the past year
- Active tobacco use
- Pregnancy
- Diabetes mellitus
- Known or suspected viral or bacterial infection
- Cohort 3: Critically ill hyperbaric patients with acute infection
- Prior treatment with hyperbaric oxygen within the last 30 days
- Consistent vitamin C or vitamin E supplementation in the past year
- Active tobacco use
- Pregnancy
- Cohort 4:
- Carbon monoxide-poisoned patients
- Prior treatment with hyperbaric oxygen within the last 30 days
- Consistent vitamin C or vitamin E supplementation in the past year
- Active tobacco use
- Pregnancy
- Time interval between removal from carbon monoxide source and first hyperbaric oxygen session >12 hours
- Cohort 5: Diabetic research subjects also undergoing glucose tolerance testing
- Prior treatment with hyperbaric oxygen within the last 30 days
- Consistent vitamin C or vitamin E supplementation in the past year
- Active tobacco use
- Cohort 6: Brain injury research subjects
- Known or suspected viral or bacterial infection
- Consistent vitamin C or vitamin E supplementation in the past year
- Active tobacco use
- Cohort 7: Hyperbaric chamber inside attendants
- Known or suspected viral or bacterial infection
- Consistent vitamin C or vitamin E supplementation in the past year
- Active tobacco use
- Prior work in the hyperbaric chamber in the last 72 hours
- Cohort 8: Healthy volunteers to receive hyperbaric oxygen
- Hyperbaric oxygen exposure within the last 30 days
- Active chronic medical condition
- Use in the past 30 days of any over-the-counter or prescription medication or dietary supplement beyond a general multivitamin
- Active tobacco use
- History of significant health problems, including metabolic bone disease, skeletal muscle pathologies, cardiac or peripheral cardiovascular system abnormalities, clotting disorders, coronary artery disease, peripheral vascular disease, stroke, cancer, high cholesterol or triglycerides, high blood pressure, diabetes mellitus, or impaired liver/kidney function.
- Morbidly obese (body mass index > 40 kg/m2)
- Pregnancy
- Known or suspected viral or bacterial infection
- Cohort 9: Healthy volunteers to breathe 100% oxygen at atmospheric pressure
- Hyperbaric oxygen exposure within the last 30 days
- Active chronic medical condition
- Use in the past 30 days of any over-the-counter or prescription medication or dietary supplement beyond a general multivitamin
- Active tobacco use
- History of significant health problems, including metabolic bone disease, skeletal muscle pathologies, cardiac or peripheral cardiovascular system abnormalities, clotting disorders, coronary artery disease, peripheral vascular disease, stroke, cancer, high cholesterol or triglycerides, high blood pressure, diabetes mellitus, or impaired liver/kidney function.
- Morbidly obese (body mass index > 40 kg/m2)
- Pregnancy
- Known or suspected viral or bacterial infection
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Intermountain Medical Center
Murray, Utah, 84157
Susan Churchill, APRN-NP, 801-408-3623, susan.churchill@imail.org
Lindell K. Weaver, MD
- Recruiting
Intermountain Healthcare, LDS Hospital
Salt Lake City, Utah, 84143
Susan Churchill, APRN-NP, 810-408-3623, Susan.Churchill@imail.org
Lindell K Weaver, MD
About this study
Official title: Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines: a Pilot Study
In this small pilot study, participants (patients and healthy volunteers) will have blood drawn before and after the study intervention (hyperbaric chamber session or normal pressure oxygen breathing. This blood will be analyzed for neutrophil oxidative burst and cytokine analysis.
Read the detailed description
The investigators are interested in studying the influence of hyperbaric oxygen on neutrophils (a kind of white blood cell) and cytokines (cell proteins). Hyperbaric oxygen can enhance the way the immune system works, but the investigators don't fully know how that happens. the investigators are doing this study to learn more about this question.
- Conditions
- Infection
- Being tested
- Hyperbaric Oxygen, Hyperbaric Air/Oxygen, Normobaric oxygen
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric OxygenDrug
Also called HBO, HBO2
Hyperbaric oxygen therapy
Hyperbaric Air/OxygenOther
Breathing air inside a hyperbaric chamber, then breathing oxygen inside a hyperbaric chamber
Normobaric oxygenOther
Breathing 100% oxygen at normal, atmospheric pressure
| Study group | Role | What they receive |
|---|---|---|
| Diabetics with active, chronic infection | Active comparator | Adult patients with diabetes mellitus and current antibiotic use for active infection will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments. Receives: Drug: Hyperbaric Oxygen |
| No diabetes or infection | Active comparator | Adult patients without diabetes and not using antibiotics will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments. Receives: Drug: Hyperbaric Oxygen |
| Critically ill patients with infection | Active comparator | Adult patients with acute, life-threatening infection for which hyperbaric oxygen is clinically indicated will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments. Receives: Drug: Hyperbaric Oxygen |
| Carbon monoxide patients | Active comparator | Adult patients with acute carbon monoxide poisoning will have blood drawn before and after their first clinical hyperbaric oxygen treatment. Receives: Drug: Hyperbaric Oxygen |
| Glucose tolerance test | Active comparator | Diabetic patients co-enrolled in a hyperbaric oxygen and glucose control study will have blood drawn before and after their glucose tolerance test and their first clinical hyperbaric oxygen treatment. Receives: Drug: Hyperbaric Oxygen |
| Brain injury research subjects | Experimental | Research subjects co-enrolled in a study examining hyperbaric oxygen for post-concussive symptoms will have blood drawn before and after their first and fourth hyperbaric chamber sessions. Receives: Drug: Hyperbaric Oxygen |
| Hyperbaric chamber inside attendants | Experimental | Hyperbaric chamber inside attendants will have their blood drawn before, mid-session, and after their chamber exposure during their regular duty day. The hyperbaric chamber exposure will include hyperbaric air and hyperbaric oxygen components (hyperbaric air/oxygen). Receives: Other: Hyperbaric Air/Oxygen |
| Volunteers, hyperbaric oxygen | Active comparator | Healthy adult volunteers will have blood drawn before and after a single hyperbaric chamber session. Receives: Drug: Hyperbaric Oxygen |
| Volunteers, normobaric pressure | Experimental | Healthy volunteers will have their blood drawn before and after breathing 100% oxygen at atmospheric pressure (normobaric oxygen) for 120 minutes. Receives: Other: Normobaric oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxidative Burst Assay
Measured: Within 30 minutes after chamber session 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindell Weaver, Intermountain Health Care, Inc.
- Investigators
- Lindell K Weaver, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563678
- Sponsor's protocol ID
- 1040229
- Acronym
- O2B
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2015
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen, Neutrophil-oxidative Burst, and Cytokines: a Pilot Study
- ClinicalTrials.gov ID
- NCT02563678
- Acronym / sponsor ID
- O2B / 1040229
- Conditions
- Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this small pilot study, participants (patients and healthy volunteers) will have blood drawn before and after the study intervention (hyperbaric chamber session or normal pressure oxygen breathing. This blood will be analyzed for neutrophil oxidative burst and cytokine analysis.
Detailed description
The investigators are interested in studying the influence of hyperbaric oxygen on neutrophils (a kind of white blood cell) and cytokines (cell proteins). Hyperbaric oxygen can enhance the way the immune system works, but the investigators don't fully know how that happens. the investigators are doing this study to learn more about this question.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Diabetics with active, chronic infection | Active comparator | Drug: Hyperbaric OxygenAdult patients with diabetes mellitus and current antibiotic use for active infection will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments. |
| No diabetes or infection | Active comparator | Drug: Hyperbaric OxygenAdult patients without diabetes and not using antibiotics will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments. |
| Critically ill patients with infection | Active comparator | Drug: Hyperbaric OxygenAdult patients with acute, life-threatening infection for which hyperbaric oxygen is clinically indicated will have blood drawn before and after their first and fourth clinical hyperbaric oxygen treatments. |
| Carbon monoxide patients | Active comparator | Drug: Hyperbaric OxygenAdult patients with acute carbon monoxide poisoning will have blood drawn before and after their first clinical hyperbaric oxygen treatment. |
| Glucose tolerance test | Active comparator | Drug: Hyperbaric OxygenDiabetic patients co-enrolled in a hyperbaric oxygen and glucose control study will have blood drawn before and after their glucose tolerance test and their first clinical hyperbaric oxygen treatment. |
| Brain injury research subjects | Experimental | Drug: Hyperbaric OxygenResearch subjects co-enrolled in a study examining hyperbaric oxygen for post-concussive symptoms will have blood drawn before and after their first and fourth hyperbaric chamber sessions. |
| Hyperbaric chamber inside attendants | Experimental | Other: Hyperbaric Air/OxygenHyperbaric chamber inside attendants will have their blood drawn before, mid-session, and after their chamber exposure during their regular duty day. The hyperbaric chamber exposure will include hyperbaric air and hyperbaric oxygen components (hyperbaric air/oxygen). |
| Volunteers, hyperbaric oxygen | Active comparator | Drug: Hyperbaric OxygenHealthy adult volunteers will have blood drawn before and after a single hyperbaric chamber session. |
| Volunteers, normobaric pressure | Experimental | Other: Normobaric oxygenHealthy volunteers will have their blood drawn before and after breathing 100% oxygen at atmospheric pressure (normobaric oxygen) for 120 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include diabetic lower extremity wounds or refractory osteomyelitis)
- Diabetes mellitus
- Current antibiotic use for active infection
- Adult patients (ages 18-65) presenting for an anticipated course of at least 4 hyperbaric oxygen sessions for chronic clinical indications (possible indications include crush injury, acute peripheral arterial insufficiency, or radiation necrosis)
- Adult patients (ages 18-65) admitted to the intensive care unit for acute, life-threatening infection where hyperbaric oxygen is clinically indicated for at least 4 sessions (possible indications include gas gangrene or necrotizing fasciitis)
Key exclusion criteria (54 listed)
- Prior treatment with hyperbaric oxygen within the last 30 days
- Consistent vitamin C or vitamin E supplementation in the past year
- Active tobacco use
- Pregnancy
- Cohort 2: Hyperbaric patients without diabetes or active infection
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 |
|---|---|---|
| Hyperbaric OxygenAlso: HBO, HBO2Hyperbaric oxygen therapy | Drug | Brain injury research subjects, Carbon monoxide patients, Critically ill patients with infection, Diabetics with active, chronic infection, Glucose tolerance test, No diabetes or infection, Volunteers, hyperbaric oxygen |
| Hyperbaric Air/OxygenBreathing air inside a hyperbaric chamber, then breathing oxygen inside a hyperbaric chamber | Other | Hyperbaric chamber inside attendants |
| Normobaric oxygenBreathing 100% oxygen at normal, atmospheric pressure | Other | Volunteers, normobaric pressure |
Primary outcome
Oxidative Burst Assay
Time frame: Within 30 minutes after chamber session 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
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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.
Lindell K Weaver, MD principal investigator
Intermountain Health Care, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hyperbaric Oxygen, Hyperbaric Air/Oxygen and Normobaric oxygen in people with Infection, run by Intermountain Health Care, Inc. at 2 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 14 inclusion and 54 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: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lindell K Weaver, MD (801-408-3623, lindell.weaver@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxidative Burst Assay (time frame: Within 30 minutes after chamber session 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2022.