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Sponsors and Collaborators: |
Southeast Renal Research Institute Dialysis Clinics, Inc. |
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Information provided by: | Southeast Renal Research Institute |
ClinicalTrials.gov Identifier: | NCT00286403 |
Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney. We hypothesize that administration of fenoldopam mesylate (a drug that increases blood flow to the kidney) to patients early in the course of their disease could reduce progression to dialysis-dependent acute renal failure. We also hypothesize that restoring blood flow could induce additional injury to the kidney through the release of reactive oxygen species. Therefore, patients in this protocol will be randomized to receive a fenoldopam or the anti-oxidant MESNA. We hypothesize that combination treatment with Fenoldopam and MESNA will decrease the incidence of death or dialysis at 21 days in patients with early post-operative acute renal failure.
Condition | Intervention | Phase |
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Acute Renal Failure |
Drug: Fenoldopam Mesylate and/or MESNA |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Combination Fenoldopam Mesylate and Intravenous MESNA (2-Mercaptoethane Sulphonate)in Early Acute Kidney Injury (AKD): A Randomized, Double-Blind Placebo Controlled Clinical Trial |
Estimated Enrollment: | 630 |
Estimated Study Completion Date: | October 2008 |
Primary Hypotheses:
The combination of fenoldopam mesylate and Intravenous MESNA reduces the level of reactive oxygen species released following restoration of renal blood flow in patients with ischemic ATN. Specific Aims
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Mean arterial pressure > 70 mm Hg receiving up to two vasopressors including:
Exclusion Criteria:
Contact: James A Tumlin, MD | 704-333-4217 | jtumlin@emory.edu |
Contact: Kelly Fields, BA | 704-927-1757 | jtumlin@emory.edu |
United States, District of Columbia | |
Chawala, M. MD | |
Washington, District of Columbia, United States, 20037 | |
United States, Tennessee | |
Mandeep Grewal | |
Chattanooga, Tennessee, United States, 37403 |
Principal Investigator: | James A Tumlin, MD | Southeast Renal Research Institute |
Study Director: | Micheal Kutner, Ph.D. | Rollins School Public Health |
Study ID Numbers: | MCAT-1 |
Study First Received: | February 1, 2006 |
Last Updated: | July 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00286403 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acute Tubular Necrosis antioxidants Fenoldopam |
Neurotransmitter Agents Renal Insufficiency Vasodilator Agents Antioxidants Cardiovascular Agents Dopamine Agonists Antihypertensive Agents Necrosis Dopamine |
Urologic Diseases Kidney Tubular Necrosis, Acute Fenoldopam Dopamine Agents Kidney Failure, Acute Kidney Diseases Renal Insufficiency, Acute Mesna Kidney Failure |
Neurotransmitter Agents Vasodilator Agents Renal Insufficiency Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Dopamine Agonists Antihypertensive Agents Protective Agents |
Pharmacologic Actions Urologic Diseases Therapeutic Uses Fenoldopam Dopamine Agents Kidney Failure, Acute Kidney Diseases Renal Insufficiency, Acute Mesna Kidney Failure |