Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship
DrKILDARE
1 other identifier
interventional
150
1 country
1
Brief Summary
We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Apr 2013
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
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 23, 2013
CompletedFirst Posted
Study publicly available on registry
July 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJune 23, 2015
June 1, 2015
1.5 years
July 23, 2013
June 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Slope of LDR (as assessed by serum cystatin-C changes)
Slope of the relationship plotting individual iodine loads against serum cystatin-C changes at 48 hours after catheterization
48 hours
Secondary Outcomes (1)
Slope of LDR (as assessed by serum creatinine changes)
72 hours
Study Arms (2)
Iodixanol
ACTIVE COMPARATORPatients randomized to coronary angiography/angioplasty with Iodixanol 320
Iobitridol
ACTIVE COMPARATORPatients randomized to coronary angiography/angioplasty with Iobitridol 350
Interventions
Eligibility Criteria
You may qualify if:
- Patients candidate to coronary angiography and/or angioplasty and
- Baseline creatinine clearance \< 60 ml/min
You may not qualify if:
- Patients with STEMI
- Patients with shock
- Known allergy to contrast media
- Prior contrast administration within 1 month
- Current use of nonsteroidal anti-inflammatory drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Misericordia Hospital, ASL 9
Grosseto, 58100, Italy
Related Publications (1)
Limbruno U, Picchi A, Micheli A, Calabria P, Cortese B, Brizi G, Severi S, De Caterina R. Refining the assessment of contrast-induced acute kidney injury: the load-to-damage relationship. J Cardiovasc Med (Hagerstown). 2014 Jul;15(7):587-94. doi: 10.2459/JCM.0b013e3283638e56.
PMID: 23811842BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
July 23, 2013
First Posted
July 25, 2013
Study Start
April 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
June 23, 2015
Record last verified: 2015-06