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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01908309

Acronym

DrKILDARE

Enrollment

150

Registered

2013-07-25

Start date

2013-04-30

Completion date

2014-10-31

Last updated

2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast Induced Acute Kidney Injury

Keywords

acute kidney injury, contrast media, cystatin-C

Brief summary

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.

Detailed 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.

Interventions

DRUGIobitridol 350

DRUGIodixanol 320

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Slope of LDR (as assessed by serum cystatin-C changes)	48 hours	Slope of the relationship plotting individual iodine loads against serum cystatin-C changes at 48 hours after catheterization

Secondary

Measure	Time frame	Description
Slope of LDR (as assessed by serum creatinine changes)	72 hours	Slope of the relationship plotting individual iodine loads against serum creatinine changes at 72 hours after catheterization

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026