NCT02476526

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: VA Greater Los Angeles Healthcare System · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Kidney Disease
• Pulmonary Embolism
• Renal Artery Stenosis
• Pulmonary Cancer

Interventions

Type	Name	Description
DRUG	Low 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)
DRUG	Acetylcysteine Inhalation	Mucomyst 1200 mg po BID x 48 hours starting the day prior to the CT scan (both experimental and control groups)
DRUG	Sodium Bicarbonate Solution	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)
PROCEDURE	64-MDCT Scanning	Both experimental and control groups will undergo 64-MDCT scanning over the thoracic area

Timeline

• Start date: 2008-09-01
• Primary completion: 2017-11-20
• Completion: 2017-11-20
• First posted: 2015-06-19
• Last updated: 2017-11-28

Locations

1 site across 1 country: United States