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

Early Phase 1CompletedNCT01908309

Azienda Sanitaria Locale 9, Grosseto150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

150

Conditions

Contrast Induced Acute Kidney Injury

Interventions

Iobitridol 350DRUG

Iodixanol 320DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Misericordia Hospital, ASL 9

Grosseto, Italy

Outcomes

Primary Outcomes

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

Time frame: 48 hours

Secondary Outcomes

Slope of LDR (as assessed by serum creatinine changes)

Slope of the relationship plotting individual iodine loads against serum creatinine changes at 72 hours after catheterization

Time frame: 72 hours

Data from ClinicalTrials.gov

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