Renal FailurePhase 2/3NCT00306306
COOL RCN: Cooling to Prevent Radiocontrast Nephropathy
A Phase 2/3 study testing Reprieve Endovascular Temperature Therapy System in people with Renal Failure and Kidney Failure, run by Radiant Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Kidney Failure, Renal Insufficiency
- What is being tested?
- Reprieve Endovascular Temperature Therapy System
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Aug 2007
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: COOL RCN: Cooling to Prevent Radiocontrast Nephropathy in Patients Undergoing Diagnostic or Interventional Catheterization
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
- Being tested
- Reprieve Endovascular Temperature Therapy System
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reprieve Endovascular Temperature Therapy SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of RCN
Equivalent safety profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2006 (estimated)
- Study startMar 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiant Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gregg Stone, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00306306
- Sponsor's protocol ID
- 50-0212
- Status last verified
- Aug 2007
- First submitted
- 21 Mar 2006
- Last updated
- 5 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COOL RCN: Cooling to Prevent Radiocontrast Nephropathy in Patients Undergoing Diagnostic or Interventional Catheterization
- ClinicalTrials.gov ID
- NCT00306306
- Acronym / sponsor ID
- 50-0212
- Conditions
- Renal Failure, Kidney Failure, Renal Insufficiency
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Radiant MedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 23 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reprieve Endovascular Temperature Therapy System | Device | – |
Primary outcome
Incidence of RCN
Equivalent safety profile
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2008.
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregg Stone, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Reprieve Endovascular Temperature Therapy System in people with Renal Failure and Kidney Failure, run by Radiant Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of RCN. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2008.