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

S

State University of New York - Upstate Medical University

Status

Not yet enrolling

Conditions

Osmolality Disturbance
Lab Interference

Treatments

Drug: Activated Charcoal

Study type

Observational

Funder types

Other

Identifiers

NCT07220031
2251702-2

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy adults

Exclusion criteria

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

Trial design

8 participants in 1 patient group

Charcoal
Description:
Healthy volunteers to consume activated charcoal
Treatment:
Drug: Activated Charcoal

Trial contacts and locations

1

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Central trial contact

Matthew Kolbeck, MD; Vincent Calleo, MD

Data sourced from clinicaltrials.gov

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