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Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship (DrKILDARE)

A

Azienda Sanitaria Locale 9, Grosseto

Status and phase

Completed
Early Phase 1

Conditions

Contrast Induced Acute Kidney Injury

Treatments

Drug: Iodixanol 320
Drug: Iobitridol 350

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 patients

Sex

All

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

Iodixanol
Active Comparator group
Description:
Patients randomized to coronary angiography/angioplasty with Iodixanol 320
Treatment:
Drug: Iodixanol 320
Iobitridol
Active Comparator group
Description:
Patients randomized to coronary angiography/angioplasty with Iobitridol 350
Treatment:
Drug: Iobitridol 350

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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