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

June 22, 2015 updated by: Ugo Limbruno, Azienda Sanitaria Locale 9, Grosseto

Contrast-inDuced nephRotoxicity as Assessed by the Cystatin-modified 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Grosseto, Italy, 58100
        • Misericordia Hospital, ASL 9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Iodixanol
Patients randomized to coronary angiography/angioplasty with Iodixanol 320
Drug: Iodixanol 320
Active Comparator: Iobitridol
Patients randomized to coronary angiography/angioplasty with Iobitridol 350
Drug: Iobitridol 350

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Sanitaria Locale 9, Grosseto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimate)

July 25, 2013

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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