Safety of Low Dose IV Contrast CT Scanning in Chronic Kidney Disease
Safety of Low Dose Intravenous Contrast 64 Multi-Detector Computed Tomography Scanning in Patients With Chronic Kidney Disease
1 other identifier
interventional
50
1 country
1
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2017
CompletedNovember 28, 2017
November 1, 2017
9.2 years
June 12, 2015
November 26, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Low Volume Contrast
EXPERIMENTALSubjects 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
Control
SHAM COMPARATORSubjects 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
Interventions
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)
Mucomyst 1200 mg po BID x 48 hours starting the day prior to the CT scan (both experimental and control groups)
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)
Both experimental and control groups will undergo 64-MDCT scanning over the thoracic area
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Greater Los Angeles Healthcare Systemlead
- General Electriccollaborator
Study Sites (1)
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
Related 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. doi: 10.7326/0003-4819-139-2-200307150-00013.
PMID: 12859163BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dean T Yamaguchi, MD, PhD
VA Greater Los Angeles Healthcare System
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Section Chief, Thoracic Radiology
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 19, 2015
Study Start
September 1, 2008
Primary Completion
November 20, 2017
Study Completion
November 20, 2017
Last Updated
November 28, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share
Results will be published after completion of study.