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NCT Number: NCT07220031

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

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.

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Key information

Conditions

Osmolality Disturbance Anthrax Bacillaceae Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lab Interference

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Upstate Medical University Clinical Research Unit

Syracuse, New York, 13210, United States

Location contact

Lauren Pacelli, BSN,RN

CONTACT

[email protected]

315-464-6201

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy adults

Exclusion criteria

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

Treatment and study plan

Activated Charcoal

Drug

This is the only intervention

Primary outcomes

Osmol Gap Change

Time frame: 6 hours

Delta serum osmolality and osmolal gap at time points 0.5, 1, 2, 4, and 6 hours after Activated charcoal given

Secondary outcomes

Ethylene Glycol

Time frame: 6 hours

Numeric result of ethylene glycol testing (measured by glycerol dehydrogenase assay) before and after charcoal.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Kolbeck, MD

CONTACT

[email protected]

315-464-6224

Vincent Calleo, MD

CONTACT

[email protected]

3154646224

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Oct 23, 2025
Registry last updated: Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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