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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02476526
• Other study ID #: Barack0001
• Status: Completed
• Phase: Phase 4
• First received: June 12, 2015
• Last updated: November 26, 2017
• Start date: September 2008
• Est. completion date: November 20, 2017

Study information

• Verified date: November 2017
• Source: VA Greater Los Angeles Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 20, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Embolism
• Kidney Diseases
• Lung Neoplasms
• Pulmonary Cancer
• Pulmonary Embolism
• Renal Artery Obstruction
• Renal Artery Stenosis
• Renal Insufficiency, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Greater Los Angeles Healthcare System	General Electric

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum in: Ann Intern Med. 2003 Oct 7;139(7):605. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Up to 72 hours after intervention