Trial | NCT01908309  Report issue

Title

Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship
Contrast-inDuced nephRotoxicity as Assessed by the Cystatin-modified KIdney Load-to-DAmage RElationship

  • Phase

    Early Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    150
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.
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 and it may allow for reliable comparative evaluations among small sized study groups randomized to different contrast media. The 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.
Study Started
Apr 30
2013
Primary Completion
Oct 31
2014
Study Completion
Oct 31
2014
Last Update
Jun 23
2015
Estimate

Drug Iobitridol 350

Drug Iodixanol 320

Iodixanol Active Comparator

Patients randomized to coronary angiography/angioplasty with Iodixanol 320

Iobitridol Active Comparator

Patients randomized to coronary angiography/angioplasty with Iobitridol 350

Criteria 

Inclusion Criteria:

Patients candidate to coronary angiography and/or angioplasty and
Baseline creatinine clearance < 60 ml/min

Exclusion Criteria:

Patients with STEMI
Patients with shock
Known allergy to contrast media
Prior contrast administration within 1 month
Current use of nonsteroidal anti-inflammatory drugs
No Results Posted