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

Phase 4

Completed

• Conditions: Chronic Kidney Disease; Pulmonary Embolism; Renal Artery Stenosis; Pulmonary Cancer
• Interventions: Drug: Acetylcysteine Inhalation; Drug: Low Volume iso-osmolar non-ionic radio contrast medium; Drug: Sodium Bicarbonate Solution; Procedure: 64-MDCT Scanning

• Registration Number: NCT02476526
• Lead Sponsor: VA Greater Los Angeles Healthcare System

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).

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-19
• Status Verified: 2017-11
• Primary Completion: 2017-11-20
• Study Completion: 2017-11-20
• Last Update Submitted: 2017-11-26
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Acetylcysteine Inhalation	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
Control	Sodium Bicarbonate Solution	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
Control	64-MDCT Scanning	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
Low Volume Contrast	Low Volume iso-osmolar non-ionic radio contrast medium	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
Low Volume Contrast	Acetylcysteine Inhalation	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
Low Volume Contrast	Sodium Bicarbonate Solution	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
Low Volume Contrast	64-MDCT Scanning	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

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

VA Greater Los Angeles Healthcare System; 🇺🇸 Los Angeles, California, United States