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Hydrogen gas may decrease the degree or incidence of brain injury following ischemia. The purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposures required for a clinical efficacy study in healthy adult participants. Participants will breathe a gas mixture that contains a low concentration of hydrogen gas in air through a high flow nasal cannula. Investigators will test for any changes in breathing and neurologic status, as well as lab tests during and following the exposure period.
Inhaled hydrogen gas (H2) has been shown to have significant protective effects on ischemic organs. Clinical trials abroad have shown promise that treatment of patients suffering from stroke, cardiac arrest, or heart attacks may benefit from inhaling hydrogen gas during the early recovery period.
The purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposures required for a clinical efficacy study in healthy adult volunteers.
Study design. Eight (8) healthy adult participants will be recruited from the greater Boston area for this study. Consenting participants will be admitted to the hospital and will undergo a series of screens (questionnaires, examination, tests) to ensure suitability to participate. Eligible and consenting participants will then undergo exposure to 2.4% H2 in medical air via high flow nasal cannula for either 24 (n=2), 48 (n=2) or 72 (n=4) hours. Participants will be screened for adverse effects as follows: vital signs every 8 hours, nursing assessment of symptoms (codified based on the National Cancer Institute's Common Terminology Criteria for Adverse Events, CTCAE) every 8 hours, bedside spirometry daily, mini-mental state exam daily, physician physical exam daily, and serum testing (blood count, chemistry, liver and coagulation profile, venous blood gas) following exposure period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrogen exposure | Experimental | The first two patients will be exposed to 2.4% hydrogen gas in medical air via HFNC for 24 hours. The second two patients will be exposed to the same gas for 48 hours. The final 4 patients will be exposed to the same gas for 72 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen | Drug | Gas exposure for 24, 48 or 72 hours via high flow nasal cannula. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse effects/symptoms | Any adverse effects will be codified according the the NCI CTCAE v5.0 | During inhalation exposure |
| Adverse effects/symptoms | Any adverse effects will be codified according the the NCI CTCAE v5.0 | 2 hours following end of exposure period |
| Adverse effects/symptoms | Any adverse effects will be codified according the the NCI CTCAE v5.0 | 24 hours following end of exposure period |
| Adverse effects/symptoms | Any adverse effects will be codified according the the NCI CTCAE v5.0 | 5 days following end of exposure period |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mini-mental state exam | Numerical change in mini mental state exam | 1 hour before end of exposure period |
| Bedside spirometry | FEV1 |
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Inclusion Criteria:
Exclusion Criteria:
Each duration group will be 50% male and 50% female.
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| Name | Affiliation | Role |
|---|---|---|
| John Kheir, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31061920 | Result | Cole AR, Perry DA, Raza A, Nedder AP, Pollack E, Regan WL, van den Bosch SJ, Polizzotti BD, Yang E, Davila D, Afacan O, Warfield SK, Ou Y, Sefton B, Everett AD, Neil JJ, Lidov HGW, Mayer JE, Kheir JN. Perioperatively Inhaled Hydrogen Gas Diminishes Neurologic Injury Following Experimental Circulatory Arrest in Swine. JACC Basic Transl Sci. 2019 Mar 27;4(2):176-187. doi: 10.1016/j.jacbts.2018.11.006. eCollection 2019 Apr. |
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The data will be shared only with the FDA and members of the DSMB and IRB.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 6, 2022 | |
| Reset | Aug 22, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 6, 2022 | Aug 22, 2023 |
| ID | Term |
|---|---|
| D006859 | Hydrogen |
| ID | Term |
|---|---|
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| 1 hour before end of exposure period |
| Bedside spirometry | Forced vital capacity | 1 hour before end of exposure period |