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

NCT ID: NCT03415997

Last Updated: 2019-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-21

Study Completion Date

2018-11-09

Brief Summary

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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

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Conditions

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Contrast Media Dosing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Total Body Weight

Group Type ACTIVE_COMPARATOR

Iohexol

Intervention Type DRUG

Iodinated contrast media

Lean Body Weight

Group Type ACTIVE_COMPARATOR

Iohexol

Intervention Type DRUG

Iodinated contrast media

Interventions

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Iohexol

Iodinated contrast media

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nova Scotia Health Authority

OTHER

Sponsor Role lead

Responsible Party

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Andreu Costa

Principal Investigator; Section Head of Abdominal Radiology, Queen Elizabeth II Health Sciences Centre; Assistant Professor, Dalhousie University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreu Costa, Md FRCPC

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

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Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

References

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Costa AF, Peet K, Abdolell M. Dosing Iodinated Contrast Media According to Lean Versus Total Body Weight at Abdominal CT: A Stratified Randomized Controlled Trial. Acad Radiol. 2020 Jun;27(6):833-840. doi: 10.1016/j.acra.2019.07.014. Epub 2019 Aug 19.

Reference Type DERIVED
PMID: 31439467 (View on PubMed)

Other Identifiers

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NSHA REB 1023119

Identifier Type: -

Identifier Source: org_study_id

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