Los Angeles, California 90073


Purpose:

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..


Study summary:

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).


Criteria:

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


NCT ID:

NCT02476526


Primary Contact:

Study Director
Dean T Yamaguchi, MD, PhD
VA Greater Los Angeles Healthcare System

Bruce M Barack, MD
Phone: 310-478-3711 ext. 41579
Email: Bruce.Barack@va.gov


Backup Contact:

Email: Elizabeth.Corey@va.gov
Elizabeth L Corey, PhD
Phone: 310-478-3711 ext. 83080


Location Contact:

Los Angeles, California 90073
United States

Elizabeth L. Corey, PhD
Phone: 310-478-3711
Email: Elizabeth.Corey@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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