Status:
TERMINATED
COOL RCN: Cooling to Prevent Radiocontrast Nephropathy
Lead Sponsor:
Radiant Medical
Conditions:
Renal Failure
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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-...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00306306
Start Date
March 1 2006
End Date
August 1 2007
Last Update
August 5 2008
Active Locations (1)
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1
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073