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

Contrast Induced Acute Kidney Injury Clinical Trial

— DrKILDARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908309
• Other study ID #: K-3
• Status: Completed
• Phase: Phase 0
• First received: July 23, 2013
• Last updated: June 22, 2015
• Start date: April 2013
• Est. completion date: October 2014

Study information

• Verified date: June 2015
• Source: Azienda Sanitaria Locale 9, Grosseto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury
• Contrast Induced Acute Kidney Injury

Intervention

Drug:
• Iobitridol 350

• Iodixanol 320

Locations

Country	Name	City	State
Italy	Misericordia Hospital, ASL 9	Grosseto

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Sanitaria Locale 9, Grosseto

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Limbruno U, Picchi A, Micheli A, Calabria P, Cortese B, Brizi G, Severi S, De Caterina R. Refining the assessment of contrast-induced acute kidney injury: the load-to-damage relationship. J Cardiovasc Med (Hagerstown). 2014 Jul;15(7):587-94. doi: 10.2459/JCM.0b013e3283638e56. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	48 hours	Yes
Secondary	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	72 hours	Yes