Aortoiliac Occlusive Disease Clinical Trial
Official title:
Carbon Dioxide Versus Iodine Contrast Medium for Endovascular Revascularization of Aortoiliac Occlusive Disease: A Two Center Randomized Controlled Trial
From July 2015 to July 2018, 64 patients with aortoiliac occlusive disease who were eligible for endovascular treatment and lacked contraindications to either iodine contrast or carbon dioxide (CO2) were randomized into the carbon dioxide CO2 group(32) or iodine contrast medium(ICM) group(32) were subjected to aortoiliac angioplasty. The primary outcome was the quality of image as the sole contrast agent used in interventions. The secondary outcomes were technical success rate and the safety of procedure.
Sampling The sample size was calculated by the intuitional review board statistician using
open epi based on the RCT done by Mendes et al. Power of study as set at 80% and confidence
interval set at 95%. The sample size was calculated to be 64 cases, 32 in each group.
Randomization All patients who qualified for the inclusion and exclusion criteria were
offered to participate in the trial after explaining all the details involved with the
potential benefits and risks of both contrast mediums. Patients who agreed were asked to sign
an informed consent. After patient data input was done, randomization was computer generated
in the vascular surgery department in Zagazig university hospitals. Computer generated random
numbers were created with the use of randomly permuted blocks with two block sizes; after
which they were secured in consecutive numbered envelopes and group allocation was
independent of time and person delivering the treatment. Single blinding was used to recruit
the patients. The patients were randomized into the following two arms: a CO2 group
(treatment arm) and an ICM group (control arm) according to the contrast medium selected for
the intervention. Group I included 32 patients who were randomized for using CO2 as the
contrast medium. Group II: involved 32 patients who were randomized for using iodine contrast
medium (ICM).
Postoperative assessment and follow-up The endovascular equipment used in each intervention
and the volumes of contrast used were accurately documented for analysis. Immediately after
the operation all patients in both arms received intravenous fluids pre and post intervention
following a local guideline for renal protection.¬ Patients were discharged the next day and
outpatient renal functions were repeated 3 days post procedure, 1 week and 1 month. We
analyzed creatinine levels between the two groups during the pre- and post-operative periods.
Any elevation of serum creatinine (Scr) of more than 25% or ≥0.5 mg/dl is defined as contrast
induced nephropathy (CIN). Patients were followed up for 1 year. One patient from the CO2
group decided to withdraw from the trial during the follow up period and was excluded from
the follow up analysis.
Imaging from all cases were analyzed on conclusion of the study. The images were reviewed by
two independent observers (radiologists with > 5 years of experience in performing
endovascular procedures) blinded to treatment arm. Image quality was assessed using Likert
rating scale ranging from 1 (very poor) to 5 (very good) for each image.18 A score of 1 was
defined as poor quality with loss of delineation of the vessel. A score of 2 was considered
below average with poor delineation of the vessel, a score of 3 is for average quality image
and medium delineation of the vessel, a score of 4 was considered good quality with clear
delineation of the vessel and a score of 5 was considered very good quality with very clear
delineation of the vessel.
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