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The goal of this observational study is to determine whether a clinically relevant dose of activated charcoal raises the serum osmolality and osmolal gap in a population of healthy volunteers. Secondarily to determine whether the same dose creates a false positive result using an enzymatic assay.
Participants will be asked to consume a dose of activated charcoal and have serial blood draws for laboratory measurements.
Healthy volunteers will be recruited and informed consent obtained. Exclusion criteria include acute illness or chronic condition requiring medication which would not be appropriate to discontinue due to risk for adsorption by activated charcoal.
Participants will fast prior to the study period and will have baseline laboratory measures (BMP, osmolality, ethanol, ethylene glycol). They will drink a dose of 1g/kg (max 100g) of activated charcoal suspension (Actidose Aqua) in water. Serial laboratory measurements will be made at 0.5, 1, 2,4, and 6 hours (including osmolality, osmolal gap, and ethylene glycol measured by enzymatic assay). These values will be compared to the pre-treatment values to determine if there is a change in the osmolal gap or ethylene glycol result from baseline.
This study is funded by the SUNY Upstate Department of Emergency Medicine and is approved by the IRB of the same institution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Charcoal | Healthy volunteers to consume activated charcoal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated Charcoal | Drug | This is the only intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Osmol Gap Change | Delta serum osmolality and osmolal gap at time points 0.5, 1, 2, 4, and 6 hours after Activated charcoal given | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Ethylene Glycol | Numeric result of ethylene glycol testing (measured by glycerol dehydrogenase assay) before and after charcoal. | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteers
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent Calleo, MD | Contact | 3154646224 | calleov@upstate.edu | |
| Matthew Kolbeck, MD | Contact | 315-464-6224 | kolbeckm@upstate.edu |
| Name | Affiliation | Role |
|---|---|---|
| Vincent Calleo, MD | Upstate Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Upstate Medical University Clinical Research Unit | Syracuse | New York | 13210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27538769 | Background | Robson AF, Lawson AJ, Lewis L, Jones A, George S. Validation of a rapid, automated method for the measurement of ethylene glycol in human plasma. Ann Clin Biochem. 2017 Jul;54(4):481-489. doi: 10.1177/0004563216667752. Epub 2016 Aug 17. | |
| 26553280 | Background | Rooney SL, Ehlers A, Morris C, Drees D, Davis SR, Kulhavy J, Krasowski MD. Use of a Rapid Ethylene Glycol Assay: a 4-Year Retrospective Study at an Academic Medical Center. J Med Toxicol. 2016 Jun;12(2):172-9. doi: 10.1007/s13181-015-0516-6. |
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| ID | Term |
|---|---|
| D000881 | Anthrax |
| ID | Term |
|---|---|
| D016863 | Bacillaceae Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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| 39007755 | Background | Huntbach W, Moss M. Rapid availability of ethylene glycol test results with enzymatic assay. Clin Toxicol (Phila). 2024 Aug;62(8):536-538. doi: 10.1080/15563650.2024.2377281. Epub 2024 Jul 15. |
| 36043532 | Background | Coulson L, Surla A, Tran V, Hoggett K. Severe glycerol intoxication mimicking toxic alcohol ingestion following large volume consumption of vanilla essence. Clin Toxicol (Phila). 2022 Nov;60(11):1248-1250. doi: 10.1080/15563650.2022.2114911. Epub 2022 Aug 31. |
| 16231712 | Background | Burkitt JM, Haskins SC, Aldrich J, Jandrey KE, Rezende ML, Boyle JE. Effects of oral administration of a commercial activated charcoal suspension on serum osmolality and lactate concentration in the dog. J Vet Intern Med. 2005 Sep-Oct;19(5):683-6. doi: 10.1892/0891-6640(2005)19[683:eooaoa]2.0.co;2. |
| D007239 | Infections |