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

Primary Purpose

Chronic Kidney Disease, Pulmonary Embolism, Renal Artery Stenosis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Low Volume iso-osmolar non-ionic radio contrast medium
Acetylcysteine Inhalation
Sodium Bicarbonate Solution
64-MDCT Scanning
Sponsored by
VA Greater Los Angeles Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • VA Greater Los Angeles Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Low Volume Contrast

Control

Arm 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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
June 12, 2015
Last Updated
November 26, 2017
Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
General Electric
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1. Study Identification

Unique Protocol Identification Number
NCT02476526
Brief Title
Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease
Official Title
Safety of Low Dose Intravenous Contrast 64 Multi-Detector Computed Tomography Scanning in Patients With Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Greater Los Angeles Healthcare System
Collaborators
General Electric

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Pulmonary Embolism, Renal Artery Stenosis, Pulmonary Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Volume Contrast
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
Sham Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Low Volume iso-osmolar non-ionic radio contrast medium
Other Intervention Name(s)
Visipaque 320
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Acetylcysteine Inhalation
Other Intervention Name(s)
Mucomyst
Intervention Description
Mucomyst 1200 mg po BID x 48 hours starting the day prior to the CT scan (both experimental and control groups)
Intervention Type
Drug
Intervention Name(s)
Sodium Bicarbonate Solution
Other Intervention Name(s)
Isotonic Sodium Bicarbonate
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
64-MDCT Scanning
Other Intervention Name(s)
64-Multi-Detector Computed Tomography Scanning
Intervention Description
Both experimental and control groups will undergo 64-MDCT scanning over the thoracic area
Primary Outcome Measure Information:
Title
Peak Serum Creatinine Level
Description
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)
Time Frame
Up to 72 hours after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean T Yamaguchi, MD, PhD
Organizational Affiliation
VA Greater Los Angeles Healthcare System
Official's Role
Study Director
Facility Information:
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be published after completion of study.
Citations:
PubMed Identifier
12859163
Citation
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. doi: 10.7326/0003-4819-139-2-200307150-00013. Erratum In: Ann Intern Med. 2003 Oct 7;139(7):605.
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Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease

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