Effect of Activated Charcoal on Serum Osmolality, Osmolal Gap, and Enzymatic Ethylene Glycol Assay
NCT ID: NCT07220031
Last Updated: 2025-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
8 participants
OBSERVATIONAL
2025-11-15
2026-05-01
Brief Summary
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1. Does a clinically relevant dose of commercially available activated charcoal raise the osmolal gap above the baseline of a healthy volunteer?
2. Does the same dose of charcoal cause a false positive enzymatic assay for ethylene glycol?
Participants will be asked to consume a dose of activated charcoal and have serial blood draws for laboratory measurements.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Charcoal
Healthy volunteers to consume activated charcoal
Activated Charcoal
This is the only intervention
Interventions
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Activated Charcoal
This is the only intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Recent illness
* Pregnancy
* Prisoners
* Non-English speaking
* Weight \> 100 kg
18 Years
ALL
Yes
Sponsors
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State University of New York - Upstate Medical University
OTHER
Responsible Party
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Principal Investigators
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Vincent Calleo, MD
Role: PRINCIPAL_INVESTIGATOR
Upstate Medical University
Locations
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Upstate Medical University Clinical Research Unit
Syracuse, New York, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2251702-2
Identifier Type: -
Identifier Source: org_study_id
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