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

Early Phase 1

Completed

• Conditions: Contrast Induced Acute Kidney Injury
• Interventions: Drug: Iodixanol 320; Drug: Iobitridol 350

• Registration Number: NCT01908309
• Lead Sponsor: Azienda Sanitaria Locale 9, Grosseto

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-24
• Study First Posted: 2013-07-25
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iodixanol	Iodixanol 320	Patients randomized to coronary angiography/angioplasty with Iodixanol 320
Iobitridol	Iobitridol 350	Patients randomized to coronary angiography/angioplasty with Iobitridol 350

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Misericordia Hospital, ASL 9; 🇮🇹 Grosseto, Italy