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

VA Greater Los Angeles Healthcare System

Status and phase: Completed; Phase 4

Conditions: Chronic Kidney Disease; Pulmonary Embolism; Renal Artery Stenosis; Pulmonary Cancer

Treatments: Procedure: 64-MDCT Scanning; Drug: Low Volume iso-osmolar non-ionic radio contrast medium; Drug: Sodium Bicarbonate Solution; Drug: Acetylcysteine Inhalation

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT02476526

Barack0001

Details and patient eligibility

About

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..

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Low Volume Contrast

Experimental group

Description:

Subjects in this arm will receive a single intravenous injection of low volume iso-osmolar non-ionic radio contrast medium, prior to undergoing 64-MDCT scanning. The use of low volume radio contrast medium constitutes the intervention. Both experimental and control groups receive a) acetylcysteine inhalation (Mucomyst) 1200 mg po BID x 48 hours starting the day prior to the CT scan; and b) isotonic Sodium Bicarbonate Solution 3ml/kg/hr iv for 1 hour prior to the CT scan and for 6 hours after the CT scan

Treatment:

Drug: Acetylcysteine Inhalation

Drug: Sodium Bicarbonate Solution

Drug: Low Volume iso-osmolar non-ionic radio contrast medium

Procedure: 64-MDCT Scanning

Control

Sham Comparator group

Description:

Subjects in this arm will undergo 64-MDCT scanning without Radio Contrast Medium (RCM). Both experimental and control groups receive a) acetylcysteine inhalation (Mucomyst) 1200 mg po BID x 48 hours starting the day prior to the CT scan; and b) isotonic Sodium Bicarbonate Solution 3ml/kg/hr iv for 1 hour prior to the CT scan and for 6 hours after the CT scan

Treatment:

Drug: Acetylcysteine Inhalation

Drug: Sodium Bicarbonate Solution

Procedure: 64-MDCT Scanning