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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Contrast Induced Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Iodixanol

Patients randomized to coronary angiography/angioplasty with Iodixanol 320

Group Type ACTIVE_COMPARATOR

Iodixanol 320

Intervention Type DRUG

Iobitridol

Patients randomized to coronary angiography/angioplasty with Iobitridol 350

Group Type ACTIVE_COMPARATOR

Iobitridol 350

Intervention Type DRUG

Interventions

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Iobitridol 350

Intervention Type DRUG

Iodixanol 320

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No