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

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ClinicalTrials.gov Identifier: NCT02476526
Recruitment Status : Completed
First Posted : June 19, 2015
Last Update Posted : November 28, 2017
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
Bruce Barack, 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..

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Pulmonary Embolism Renal Artery Stenosis Pulmonary Cancer Drug: Low Volume iso-osmolar non-ionic radio contrast medium Drug: Acetylcysteine Inhalation Drug: Sodium Bicarbonate Solution Procedure: 64-MDCT Scanning Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety of Low Dose Intravenous Contrast 64 Multi-Detector Computed Tomography Scanning in Patients With Chronic Kidney Disease
Study Start Date : September 2008
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : November 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low Volume Contrast
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
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)
Other Name: Visipaque 320

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

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)
Other Name: Isotonic Sodium Bicarbonate

Procedure: 64-MDCT Scanning
Both experimental and control groups will undergo 64-MDCT scanning over the thoracic area
Other Name: 64-Multi-Detector Computed Tomography Scanning

Sham Comparator: Control
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
Drug: Acetylcysteine Inhalation
Mucomyst 1200 mg po BID x 48 hours starting the day prior to the CT scan (both experimental and control groups)
Other Name: Mucomyst

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)
Other Name: Isotonic Sodium Bicarbonate

Procedure: 64-MDCT Scanning
Both experimental and control groups will undergo 64-MDCT scanning over the thoracic area
Other Name: 64-Multi-Detector Computed Tomography Scanning




Primary Outcome Measures :
  1. Peak Serum Creatinine Level [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476526


Locations
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United States, California
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States, 90073
Sponsors and Collaborators
VA Greater Los Angeles Healthcare System
General Electric
Investigators
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Study Director: Dean T Yamaguchi, MD, PhD VA Greater Los Angeles Healthcare System

Publications:
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Responsible Party: Bruce Barack, Section Chief, Thoracic Radiology, VA Greater Los Angeles Healthcare System
ClinicalTrials.gov Identifier: NCT02476526     History of Changes
Other Study ID Numbers: Barack0001
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Results will be published after completion of study.

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Embolism
Pulmonary Embolism
Renal Artery Obstruction
Lung Neoplasms
Urologic Diseases
Renal Insufficiency
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Arterial Occlusive Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Pharmaceutical Solutions
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs