COOL RCN: Cooling to Prevent Radiocontrast Nephropathy
Renal Failure, Kidney Failure, Renal Insufficiency
About this trial
This is an interventional prevention trial for Renal Failure
Eligibility Criteria
Inclusion Criteria: Subject is greater than 18 years of age. Subject has a calculated creatinine clearance of 20-50 mL/min (within 10 days prior to enrollment), per the Cockcroft-Gault formula. Subject is eligible for coronary angiography (with or without ventriculogram) and/or percutaneous coronary intervention in which it is anticipated that > 50cc of radiographic contrast will be administered. Subject agrees to comply with the study procedures, including repeat phlebotomy and clinical follow-up. Subject or subject's legal representative is willing to provide written, informed consent to participate in this clinical study. 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.
Sites / Locations
- William Beaumont Hospital