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

VA Greater Los Angeles Healthcare System50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease Pulmonary Embolism Renal Artery Stenosis Pulmonary Cancer

Interventions

Low Volume iso-osmolar non-ionic radio contrast mediumDRUG

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)

Acetylcysteine InhalationDRUG

Mucomyst 1200 mg po BID x 48 hours starting the day prior to the CT scan (both experimental and control groups)

Sodium Bicarbonate SolutionDRUG

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)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Outcomes

Primary Outcomes

Peak Serum Creatinine Level

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)

Time frame: Up to 72 hours after intervention

Data from ClinicalTrials.gov

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