Vasodilators and Anti-Oxidant Therapy in Early ATN

• Status: Withdrawn
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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 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. The investigators 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. The investigators 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southeast Renal Research Institute
• Collaborator: Dialysis Clinic, Inc.
• Treatments: Fenoldopam; Mesna

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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