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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07220031
Enrollment
8
Registered
2025-10-23
Start date
2025-11-15
Completion date
2026-05-01
Last updated
2025-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osmolality Disturbance, Lab Interference

Keywords

activated charcoal, serum osmolality, osmolal gap, ethylene glycol, glycerol dehydrogenase

Brief summary

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

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.

Interventions

This is the only intervention

Sponsors

State University of New York - Upstate Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy adults

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Osmol Gap Change6 hoursDelta serum osmolality and osmolal gap at time points 0.5, 1, 2, 4, and 6 hours after Activated charcoal given

Secondary

MeasureTime frameDescription
Ethylene Glycol6 hoursNumeric result of ethylene glycol testing (measured by glycerol dehydrogenase assay) before and after charcoal.

Countries

United States

Contacts

Primary ContactVincent Calleo, MD
calleov@upstate.edu3154646224
Backup ContactMatthew Kolbeck, MD
kolbeckm@upstate.edu315-464-6224

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026