Effect of Activated Charcoal on Serum Osmolality, Osmolal Gap, and Enzymatic Ethylene Glycol Assay

NCT ID: NCT07220031

Last Updated: 2025-10-23

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-15

Study Completion Date

2026-05-01

Brief Summary

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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.

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.

Detailed Description

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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.

Conditions

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Osmolality Disturbance Lab Interference

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Charcoal

Healthy volunteers to consume activated charcoal

Activated Charcoal

Intervention Type DRUG

This is the only intervention

Interventions

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Activated Charcoal

This is the only intervention

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults

Exclusion Criteria

* Any medical comorbidities
* Recent illness
* Pregnancy
* Prisoners
* Non-English speaking
* Weight \> 100 kg
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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State University of New York - Upstate Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Central Contacts

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Vincent Calleo, MD

Role: CONTACT

3154646224

Matthew Kolbeck, MD

Role: CONTACT

315-464-6224

Facility Contacts

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Lauren Pacelli, BSN,RN

Role: primary

315-464-6201

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.

Reference Type BACKGROUND
PMID: 27538769 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26553280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 39007755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36043532 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16231712 (View on PubMed)

Other Identifiers

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2251702-2

Identifier Type: -

Identifier Source: org_study_id

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