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

Phase 4

Completed

• Conditions: Contrast Media Dosing
• Interventions: Drug: Iohexol

• Registration Number: NCT03415997
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-01-30
• Study Start: 2018-02-21
• Primary Completion: 2018-11-09
• Study Completion: 2018-11-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Total Body Weight	Iohexol	-
Lean Body Weight	Iohexol	-

Primary Outcome Measures

Name	Time	Method
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 hour	Images 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 Outcome Measures

Name	Time	Method
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 hour	Images 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.

Trial Locations

Locations (1)

Queen Elizabeth II Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada