COOL RCN: Cooling to Prevent Radiocontrast Nephropathy

Exclusion Criteria

• •Subject is currently undergoing renal dialysis.
• •Subject is in acute renal failure or has unstable renal function as evidenced by clinical findings or a change in serum creatinine of \>= 0.5 mg/dL or \>= 25% within 10 days prior to enrollment.
• •Subject is undergoing planned renal artery catheterization, or infusion of medications or therapeutic agents directly into the renal arteries.
• •Subject is hypotensive \[systolic blood pressure (SBP) \<100 mmHg\].
• •Subject has had an acute ST-segment elevation myocardial infarction (MI) within 72 hours prior to enrollment, or is currently having an acute ST-segment elevation MI.
• •Subject has decompensated heart failure as defined by the requirement for IV diuretic, inotropic or vasopressor support within the last 7 days.
• •Subject requires respiratory support.
• •Subject has a known allergy to iodine-based contrast agents that cannot be pre-medicated.
• •Subject has received a radiographic contrast agent within 10 days prior to enrollment or a second imaging study is planned within the next 10 days.
• •Subject is receiving mannitol or IV diuretics.
• •Subject has known renal artery stenosis.
• •Subject is currently on a course of chemotherapy.
• •Subject has any serious medical condition, which in the opinion of the investigator is likely to interfere with study procedures.
• •A plan exists for the addition, discontinuation or dose-adjustment of ACE inhibitors, angiotensin II blockers, trimethoprim, cimetidine, metoclopramide, bromocriptine, levadopa, non-steroidal anti inflammatory drugs (NSAIDs), COX-2 inhibitors, or catechol-O-methyltransferase (COMT) inhibitors (e.g., encapone or tolcapone) at any time during the study.
• •Subject has a known hypersensitivity to hypothermia, including a history of Raynaud's Disease.
• •Subject has a known hypersensitivity to heparin which cannot be adequately pre-medicated
• •Subject has a known history of bleeding diathesis, coagulopathy, sickle cell disease, cryoglobulinemia, or will refuse blood transfusions.
• •Subject has a height of \< 1.5 m (4 feet 11 inches).
• •Subject has an Inferior Vena Cava filter in place.
• •Subject is pregnant. (Female subjects of childbearing potential must have a negative serum or urine human chorionic gonadotropin (hCG) pregnancy test prior to enrollment)
• •Subject has a known hypersensitivity to buspirone hydrochloride or meperidine and/or has been treated with a monoamine oxidase inhibitor in the past 14 days.
• •Subject has a known history of severe hepatic impairment, untreated hypothyroidism, Addison's Disease, or Benign Prostatic Hypertrophy or urethral stricture that in the physician's opinion would be incompatible with meperidine administration.
• •Subject has a known, unresolved history of drug use or alcohol dependency, lacks the ability to comprehend or follow instructions, or would be unlikely to comply with study follow-up requirements.
• •Subject is currently enrolled in this trial or in another investigational drug or device trial. Note: For the purpose of this protocol, subjects involved in extended follow-up trials for products that were investigational but are currently commercially available are not considered enrolled in an investigational trial.