Patient Tailored Contrast Volume for Preoperative CT Angiography of the Aorta

Not Applicable

Completed

• Conditions: Aortic Aneurysm
• Interventions: Other: Contrast dose reduction, CT-angiography

• Registration Number: NCT05716568
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

An in-house calculator was developed to calculate the appropriate contrast dose, rather than standardly administering a 120ml dose. This study aims for a more uniform contrast enhancement in patients by means of adjusting (lowering) contrast dose to patient parameters.

Detailed Description

Until now, CT scans in our and many other institutions are being performed with a fixed standard contrast dose specific for every protocol, independent of patient characteristics. However, many if not all patients would benefit from a contrast dose reduction, as long as image quality is not impaired. This is especially beneficial to patients with impaired renal function.

For this purpose, we researched previous literature as well as data from previously scanned patients with standard dose, to formulate a contrast dose calculation adapted to patient parameters.

An in-house calculator was developed to calculate the optimal contrast dose dependent on patient length, weight and heartrate.

A total of 60 CT-scans will be performed and retrospectively collected. Patients are randomly assigned to one of three groups : 1/ Standard dose of 120ml; 2/ Calculated dose (40-150ml) 3/ Calculated dose -50% (20-120ml). In case of reduced kidney function, patients were randomly divided between group 2 and 3 (reduced contrast dose).

Study Timeline

• Study Start: 2014-04
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2023-01-27
• Last Update Submitted: 2023-01-27
• Study First Posted: 2023-02-08
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients requiring CT-angiography of the aorta as requested by clinician
• For aneurysm detection or follow-up
• Or for dissection follow-up
• Thoraco-abdominal aorta or abdominal aorta

Exclusion Criteria

• Contra-indications for contrast administration (severe renal impairment or adverse reactions)
• Previously endovascular repair of the aorta
• Only thoracic aorta
• No informed consent
• Contrast injection at 4cc/second not possible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Calculated contrast dose	Contrast dose reduction, CT-angiography	Contrast dose by calculation
Standard contrast dose	Contrast dose reduction, CT-angiography	Standard contrast dose administration
Calculated contrast dose -50%	Contrast dose reduction, CT-angiography	Contrast dose by calculation, with extra dilution by 50%.

Primary Outcome Measures

Name	Time	Method
Reduction in contrast dose	Through study completion, an average of 1 year	Reduction in contrast dose while maintaining image quality