Primary Objective: Is it possible to reduce the amount of contrast medium used in CTAs of the abdominal aorta by injecting the contrast medium with a multiphasic protocol, without losing image quality?Secondary Objective: What does the contrast…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The amount of HU measured in the aorta at 30 positions from the celiac trunk
to the iliac arteries in both groups.
Secondary outcome
- The contrast enhancement curve over time in the aorta in the multiphasic
protocol.
- The uniformity of the attenuation values of both protocols.
- The volume of contrast medium that is used.
- The clinical usefulness of the scans determined by 3 blinded radiologists (of
whom one is not connected to the Jeroen Bosch Ziekenhuis) and scored at a scale
from 1 to 3.
Background summary
The amount of contrast medium delivered to a patient is of utmost concern due
to the risks of complications, particularly contras-induced nephropathy (CIN).
CIN is the third most common cause of hospital-acquired acute renal failure.
CIN leads to prolonged hospitalization and higher medical costs. Therefore,
ways to reduce the amount of contrast media are highly anticipated.
In literature the multiphasic injection method is described, in which the rate
of injection exponentially decays, opposed to the current uniphasic technique
that injects with a constant rate. Multiphasic injection is found to achieve
better uniform prolonged enhancement, which is desirable, and can yield the
same quality scans with a smaller amount of contrast medium.
Patients undergoing an angiographic CT (CTA) scan of the abdominal aorta at the
Jeroen Bosch hospital, receive 100 ml of 350 mg/ml iodine containing contrast
material. Using the multiphasic injection technique we will reduce this amount
to 89 ml.
Study objective
Primary Objective: Is it possible to reduce the amount of contrast medium used
in CTAs of the abdominal aorta by injecting the contrast medium with a
multiphasic protocol, without losing image quality?
Secondary Objective: What does the contrast enhancement curve over time looks
like using the multiphasic injection technique?
With which protocol a more uniform contrast enhancement is reached?
Study design
Intervention study, feasibility study
Intervention
30 Patients are randomly assigned to either standard or multiphasic protocol.
15 Patients undergo standard protocol, 15 patients undergo the multiphasic
protocol. The multiphasic protocol injects contrast medium with an exponential
decay; the total volume of contrast medium is injected is less (89 ml instead
of 100 ml). For research purposes low-dose scans will be made for an additional
20 seconds after the diagnostic scan is finished, at the position where the
diagnostic scan stopped.
Study burden and risks
There is a risk that the scans of patients undergoing the multiphasic protocol
will be of less quality, since less contrast medium is used. Worst-case
scenario is that the patient will have to undergo another scan. Immediately
after scanning the patients, the scans will be looked at by a radiologist to
see if the image quality is sufficient. So when image quality is not
sufficient, patients will be scanned again immediately and an additional needle
prick is not necessary. The patients undergoing the multiphasic protocol will
be subjected to a small additional amount of radiation, approximately 1 mSv,
because of the low-dose scans that will be made after finishing the diagnostic
scan.
Henri Dunantlaan 1
5223 GZ 's-Hertogenbosch
NL
Henri Dunantlaan 1
5223 GZ 's-Hertogenbosch
NL
Listed location countries
Age
Inclusion criteria
- Referred for CTA of the abdominal aorta according to clinical indications
- Signed informed consent
- > 18 years
- Mentally competent
- Kidney function > 60 GFR
Exclusion criteria
- Kidney function < 60 GFR
- Allergy contrast medium
- Known arrhythmias or other heart disorders
- <18 years
- Pregnancy or lactation
- Mentally incompetent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL37432.028.11 |