Status:
WITHDRAWN
Vasodilators and Anti-Oxidant Therapy in Early ATN
Lead Sponsor:
Southeast Renal Research Institute
Collaborating Sponsors:
Dialysis Clinic, Inc.
Conditions:
Acute Renal Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Patients developing kidney failure after open heart surgery experience an abrupt decrease in blood flow to the kidney. The investigators hypothesize that administration of fenoldopam mesylate (a drug ...
Detailed Description
Primary Hypotheses: * Combination therapy with intravenous fenoldopam mesylate and MESNA will reduce the incidence of dialysis and all cause mortality at 21 days in patients with established acute tu...
Eligibility Criteria
Inclusion
- Post-operative patients with serum creatinine (Cr) rising 0.3 mg/dl or more than 25% above admission levels within a single 24-hour period will be considered eligible.
- Central Venous Access: \[CVP \> 6 cm H2O without mechanical ventilation\] \[CVP \> 9 cm H2O with mechanical ventilation\]
- Mean arterial pressure \> 70 mm Hg receiving up to two vasopressors including:
- Nor-epinephrine (0.01-1.5g/kg/min)
- Phenylephrine (0.1-7.0g/kg/min
- Vasopressin (0.1-1.5 mU/kg/min)
Exclusion
- Patients with APACHE scores greater than 30 (or felt by the principal investigators to be unlikely survive more than 24 hours).
- Patients requiring 3 or more presser agents to maintain a MAP of 70 mm Hg or greater.
- Patients on two vasopressors with a MAP \< 70 mm Hg will not be considered for enrollment
- Patient with baseline serum Cr \> 3.0 mg/dl
- Patients with known bacteremia and/or the Systemic Inflammatory Response Syndrome (SIRS)
- Patients ATN secondary to aminoglycosides or amphotericin B or equivalent anti-fungal drug
- Patients on chronic peritoneal or hemodialysis
- Patients receiving acute peritoneal or hemodialysis during current hospitalization
- Patients on dopamine infusion within the previous 12 hours
- Patients with known HIV seropositivity and past history of opportunistic infection
- Pregnant or lactating women
- Patients with history of uncontrolled atrial or ventricular cardiac arrhythmia
- Patients under the influence of alcohol or other drugs
- Patients enrolled in a previous investigational study within15 days of enrollment
- Patients with a known hypersensitivity to fenoldopam mesylate
- Patients with a known history of glaucoma.
- Patients with cirrhosis of the liver and/or portal hypertension
- Patients with toxic levels of calcineurin inhibitors (FK-506 or CsA) or acute allograft rejection
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00286403
Start Date
August 1 2008
End Date
October 1 2008
Last Update
March 28 2016
Active Locations (2)
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1
Chawala, M. MD
Washington D.C., District of Columbia, United States, 20037
2
Mandeep Grewal
Chattanooga, Tennessee, United States, 37403