search
Back to results

COOL RCN: Cooling to Prevent Radiocontrast Nephropathy

Primary Purpose

Renal Failure, Kidney Failure, Renal Insufficiency

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Reprieve Endovascular Temperature Therapy System
Sponsored by
Radiant Medical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Incidence of RCN
Equivalent safety profile

Secondary Outcome Measures

Full Information

First Posted
March 21, 2006
Last Updated
August 4, 2008
Sponsor
Radiant Medical
search

1. Study Identification

Unique Protocol Identification Number
NCT00306306
Brief Title
COOL RCN: Cooling to Prevent Radiocontrast Nephropathy
Official Title
COOL RCN: Cooling to Prevent Radiocontrast Nephropathy in Patients Undergoing Diagnostic or Interventional Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radiant Medical

4. Oversight

5. Study Description

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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Kidney Failure, Renal Insufficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Reprieve Endovascular Temperature Therapy System
Primary Outcome Measure Information:
Title
Incidence of RCN
Title
Equivalent safety profile

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregg Stone, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Learn more about this trial

COOL RCN: Cooling to Prevent Radiocontrast Nephropathy

We'll reach out to this number within 24 hrs