Chronic Kidney Disease, Pulmonary Cancer, Pulmonary Embolism, Renal Artery Stenosis
Conditions
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).
Interventions
DRUGLow Volume iso-osmolar non-ionic radio contrast medium
Intravenous injection of low volume (30 cc) iso-osmolar non-ionic radio contrast medium as part of the 64-MDCT Scanning procedure (intervention group only)
DRUGAcetylcysteine Inhalation
Mucomyst 1200 mg po BID x 48 hours starting the day prior to the CT scan (both experimental and control groups)
Isotonic Sodium Bicarbonate 3 ml/kg/hr iv for 1 hour prior to the CT scan and for 6 hours after the CT scan (both experimental and control groups)
PROCEDURE64-MDCT Scanning
Both experimental and control groups will undergo 64-MDCT scanning over the thoracic area
Sponsors
General Electric
VA Greater Los Angeles Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Serum Creatinine Level | Up to 72 hours after intervention | The peak serum creatinine increase over baseline within 72 hours after intervention is the outcome variable. This variable is used for comparison between two groups, as well as for safety monitoring in the intervention group (25% increase is the upper threshold) |
Countries
United States
Outcome results
None listed