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

Sponsor

Nova Scotia Health Authority (Other)

Overall Status

Completed

CT.gov ID

NCT03415997

Collaborator

(none)

239

Enrollment

Location

Arms

8.6

Actual Duration (Months)

27.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast Media Dosing	Drug: Iohexol	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

239 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 21, 2018

Actual Primary Completion Date :

Nov 9, 2018

Actual Study Completion Date :

Nov 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Total Body Weight	Drug: Iohexol Iodinated contrast media
Active Comparator: Lean Body Weight	Drug: Iohexol Iodinated contrast media

Arm

Intervention/Treatment

Active Comparator: Total Body Weight

Drug: Iohexol

Iodinated contrast media

Active Comparator: Lean Body Weight

Drug: Iohexol

Iodinated contrast media

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia	Canada	B3H 2Y9

Sponsors and Collaborators

Nova Scotia Health Authority

Investigators

Principal Investigator: Andreu Costa, Md FRCPC, Nova Scotia Health Authority

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Andreu Costa, Principal Investigator; Section Head of Abdominal Radiology, Queen Elizabeth II Health Sciences Centre; Assistant Professor, Dalhousie University, Nova Scotia Health Authority

ClinicalTrials.gov Identifier:

NCT03415997

Other Study ID Numbers:

NSHA REB 1023119

First Posted:

Jan 30, 2018

Last Update Posted:

Jan 31, 2019

Last Verified:

Jan 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Body Weight

Study Results

No Results Posted as of Jan 31, 2019