NCT00306306

COOL RCN: Cooling to Prevent Radiocontrast Nephropathy

COOL RCN: Cooling to Prevent Radiocontrast Nephropathy in Patients Undergoing Diagnostic or Interventional Catheterization

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Radiant Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Radiographic contrast agents are administered to all patients undergoing diagnostic or interventional catheterization procedures. Injection of contrast enables visualization of the vasculature with X-ray based fluoroscopy or cineangiographic imaging. Unfortunately, the use of radiographic contrast agents is often associated with severe adverse side effects, including acute kidney failure. Acute kidney failure following exposure to an intravascular contrast agent is also known as Radiocontrast Nephropathy (RCN). Physiologic factors that may put a patient at higher risk of developing RCN include: pre-existing renal insufficiency, diabetes mellitus, age, cardiovascular disease (particularly congestive heart failure and low ejection fraction), and dehydration or other conditions characterized by depletion of effective circulatory volume. These risk factors are relatively common in patients undergoing catheterization procedures. Treatment of high-risk patients can be modified, by hydration and/or minimizing contrast volume; however despite these efforts, RCN remains a well-recognized complication of coronary catheterization procedures. Given the frequency and detrimental consequences of RCN, there is a compelling clinical need for safe and effective therapies to reduce the incidence of RCN. One such potential therapy is endovascular cooling to induce mild hypothermia. This study has been designed to evaluate whether endovascular cooling can reduce the incidence of RCN in high-risk patients who are undergoing diagnostic or interventional catheterization procedures.

Conditions

• Renal Failure
• Kidney Failure
• Renal Insufficiency

Interventions

Type	Name	Description
DEVICE	Reprieve Endovascular Temperature Therapy System

Timeline

• Start date: 2006-03-01
• Completion: 2007-08-01
• First posted: 2006-03-23
• Last updated: 2008-08-05

Locations

1 site across 1 country: United States