Renin-angiotensin-aldosterone System (RAAS) Blockade and Contrast Induced Nephropathy

Radiographic Contrast Agent Nephropathy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01525888
• Other study ID #: SOR21711CTIL
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: June 4, 2015
• Start date: February 2012
• Est. completion date: December 2013

Study information

• Verified date: January 2012
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the current study is to evaluate prospectively whether concomitant administration of renin-angiotensin-aldosterone system (RAAS) blockers (namely ACE-I and ARBs') influence the change in estimated glomerular filtration rate or GFR (eGFR) after administration of contrast media in patients undergoing non-emergent coronary angiography.

Description:

Contrast-induced nephropathy (CIN) is defined as an absolute or relative increase in serum creatinine compared to the baseline values, together with exposure to a contrast agent and exclusion of alternative explanations for renal impairment. Most frequently the renal impairment develops 48 hours post exposure. Although RAAS blocking agents are widely used among patients requiring contrast studies, data regarding the effect of these agents on the development of CIN are sparse and inconsistent. Patients undergoing percutaneous coronary intervention are frequently treated with RAAS blocking agents. Despite the not infrequent occurrence of CIN following percutaneous coronary intervention (PCI) no guidelines are available on the topic of the cessation of the RAAS inhibitors prior to the procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years,

• chronic therapy with ACE-I and/or ARBs' (confirmed by electronic records in their medical file) and

• planned coronary angiography

Exclusion Criteria:

• chronic utilization of NSAIDS and Cox-2 selective inhibitors,

• chronic treatment with mineralocorticosteroid receptor blocker, and

• administration of contrast within 14 days prior to the enrollment.

Related Conditions & MeSH terms

• Kidney Diseases
• Radiographic Contrast Agent Nephropathy

Intervention

Procedure:
• stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)
stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in eGFR from baseline to 48-72 hours following the exposure to the contrast.		48 AND 72 HOURS AFTER EXPOSURE TO CONTRAST MEDIA