Clinical trial NCT02476526: Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease
Official title: Safety of Low Dose Intravenous Contrast 64 Multi-Detector Computed Tomography Scanning in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Pulmonary Embolism
Renal Artery Stenosis
Pulmonary Cancer
Lead sponsor: VA Greater Los Angeles Healthcare System
Sponsor class: FED
Collaborators: name: General Electric
First posted: 2015-06-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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..

Detailed description: 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).

Eligibility 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

Primary outcomes:
measure: Peak Serum Creatinine Level
timeFrame: Up to 72 hours after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System
name: Dean T Yamaguchi, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Levey AS, Coresh J, Balk E, Kausz AT, Levin A, Steffes MW, Hogg RJ, Perrone RD, Lau J, Eknoyan G; National Kidney Foundation. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med. 2003 Jul 15;139(2):137-47. doi: 10.7326/0003-4819-139-2-200307150-00013.