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Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight

Dosing Iodinated Contrast Media According to Lean vs. Total Body Weight at Abdominal CT: a North American Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03415997
Enrollment
239
Registered
2018-01-30
Start date
2018-02-21
Completion date
2018-11-09
Last updated
2019-01-31

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

Conditions

Contrast Media Dosing

Brief summary

The purpose of this study is to evaluate the effect of dosing iodinated contrast media according to a patient's total body weight vs. lean body weight. Participants will be randomized into 2 groups based on contrast dosing technique, and solid organ enhancement at uniphasic abdominal CT will be measured.

Interventions

DRUGIohexol

Iodinated contrast media

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

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

Inclusion criteria

* outpatients only * patients scanned on modern Siemens scanners at our institution

Exclusion criteria

* self-reported history of chronic kidney, heart or liver disease * allergy to iodinated contrast * acute illness * outside maximum threshold limit for weight-based contrast dosing * pregnancy * image degradation

Design outcomes

Primary

MeasureTime frameDescription
Mean hepatic enhancement (MHE): difference in liver attenuation on computed tomography images acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)1 hourImages of the liver will be obtained before and after administration of iodinated contrast media. Regions of interest will be drawn on these pre- and post- contrast computed tomography (CT) images of the liver. The average attenuation before and after contrast administration will be calculated. The mean hepatic enhancement (MHE) will be calculated as the average attenuation post-contrast minus the average attenuation pre-contrast. This will provide a measure of liver enhancement.

Secondary

MeasureTime frameDescription
Standard deviation in mean hepatic enhancement (sigma MHE): standard deviation in the difference in liver attenuation on CT acquired before and after administration of contrast (in portal venous phase), as measured in Hounsfield units (HU)1 hourImages of the liver will be obtained before and after administration of iodinated contrast media. Regions of interest will be drawn on these pre- and post- contrast computed tomography images of the liver. The average attenuation before and after contrast administration will be calculated. The mean hepatic enhancement (MHE) will be calculated as the average attenuation post-contrast minus the average attenuation pre-contrast. The standard deviation in MHE will provide a measure of inter-patient variability.

Countries

Canada

Outcome results

None listed

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