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

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

NCT01908309

K-3

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

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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