Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease



Status:Completed
Conditions:Lung Cancer, Renal Impairment / Chronic Kidney Disease, Cardiology, Nephrology
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology, Oncology
Healthy:No
Age Range:18 - Any
Updated:11/30/2017
Start Date:September 2008
End Date:November 20, 2017

Use our guide to learn which trials are right for you!

Safety of Low Dose Intravenous Contrast 64 Multi-Detector Computed Tomography Scanning in Patients With Chronic Kidney Disease

The purpose of this study is to show that the use of low volume iso-osmolar non-ionic radio
contrast medium (30 cc) in a thoracic CT Scanning procedure in a selected group of patients
with chronic kidney disease (CKD) will avoid contrast induced nephropathy (CIN) in comparison
to a similar group of patients with CKD who receive no contrast medium..

The use of radio contrast medium enhances the image quality of CT scans. However, contrast CT
is avoided in patients with CKD for fear of contrast-induced nephropathy. The current
standard of care for these patients is CT without contrast. Taking advantage of fast scanning
capabilities of modern CT scanners (64-Multi-Detector CT), the current investigators have
developed a method to use low volume iso-osmolar non-ionic radio contrast medium (30 cc)
which can be used in a selected group of adult patients with mild to moderate stable CKD
(eGFR 16-60 ml/min/m^2 for at least 12 months), who require thoracic CT imaging for
diagnostic purposes. Up to 100 patients who meet the inclusion/exclusion criteria will be
randomized to standard care (no-contrast, 50 controls) or low volume contrast CT (50
intervention group). The peak increase of serum creatinine levels within 72 hours after the
CT procedure will be measured as an outcome variable for comparison between the two groups,
as well as a safety monitoring variable in the intervention group (25% increase is the upper
threshold).

Inclusion Criteria:

- Subjects with documented stable Chronic Kidney Disease (CKD) defined as a stable eGFR
16-60 ml/min/m^2 for ≥ 12 months; and

- Referred to CT scanning procedure to evaluate pulmonary embolism, pulmonary
malignancy, acute aortic syndromes, or renal artery stenosis.

Exclusion Criteria:

- CKD Stages 1, 2 and 5

- Stage 3-4 congestive heart failure (CHF)

- Irregular supraventricular tachycardia

- Allergic to iodinated Radio Contrast Medium (RCM)

- Allergic to Mucomyst

- Pregnancy

- Evidence of acute renal failure (ARF)

- Serum bicarbonate either less than 20 meq/L or greater than 35 meq/L

- Hydration with a bicarbonate solution is contraindicated or considered unsafe by the
subject's caring physicians
We found this trial at
1
site
Los Angeles, California 90073
Principal Investigator: Bruce M Barack, MD
Phone: 310-478-3711
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials