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Completed

NCT Number: NCT01908309

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

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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Key information

Conditions

Contrast Induced Acute Kidney Injury Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Misericordia Hospital, ASL 9

Grosseto, 58100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Iobitridol 350

Drug

Iodixanol 320

Drug

Primary outcomes

  1. Slope of LDR (as assessed by serum cystatin-C changes)

    Time frame: 48 hours

    Slope of the relationship plotting individual iodine loads against serum cystatin-C changes at 48 hours after catheterization

Secondary outcomes

  1. Slope of LDR (as assessed by serum creatinine changes)

    Time frame: 72 hours

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

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale 9, Grosseto

Other Gov

Registry information

Official study title

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

Acronym: DrKILDARE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2013
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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