Intra-Renal Therapy of Diuretic Unresponsive Acute Kidney Injury

Withdrawn before enrolling · Phase 4

Conditions studied: Kidney Failures, Acute

In brief

Randomized prospective trial of patients with diuretic unresponsive acute kidney injury where patients will receive standard supportive therapy with diuretics versus intra-renal delivery of the vasodilator fenoldopam mesylate. Patients with rising creatinine who fail to respond to bolus diuretics will be treated with a prolonged course of diuretics or undergo placement of a catheter within the renal arteries that allows for infusion of fenoldopam mesylate. The rational is that early delivery of a high dose vasodilator may reverse the decline of renal function in patients with severe acute kidney injury.

Key facts

Study ID

NCT01073189

Run by

Southeast Renal Research Institute

People needed

0

Starts

2010-04-01

Expected to finish

2011-01-01

Last updated by the study team

2016-03-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inclusion Criteria:
• Any patient age 18 or over with a 1.0 mg/dl rise in serum Cr within 48 hours or a fall in urine output of less than 20 mls/min X 2 consecutive hours.
• AND one of the two following Options
• Failure to double urine output within two hours of a 1.5 mg/kg bolus Furosemide -OR-
• Failure to maintain a 50% increase in urine output for 4 consecutive hours following a single 1.5 mg/kg bolus of furosemide WITH an MD performed Urinalysis documenting the presence of 3 or more "muddy brown casts" per low powered field (LPF) or the presence of a "free renal tubular cells"

You may not qualify if…

• Exclusion Criteria:
• Patients with APACHE scores greater than 25 (or felt by the principle investigators not to survive more than 24 hours)
• Patients with a MAP < 65 on two or more vasopressor or any patient requiring 3 or more presser agents (nor epinephrine, + epinephrine or vasopressin) to maintain a MAP of 65 mm Hg .
• Patients receiving acute or chronic peritoneal or hemodialysis during current hospitalization
• Patients receiving dopamine or fenoldopam infusion within the previous 24 hours
• Patients requiring hemodynamic support with an intra-aortic balloon pump
• Patients with known HIV seropositivity
• Pregnant or lactating women
• Patients actively receiving NSAIDS or COX-2 antagonists
• Patients with history of uncontrolled cardiac arrhythmia
• Patients who cannot give informed consent.
• Patients with a known hypersensitivity to fenoldopam mesylate
• Patients with known bleeding diathesis
• Patients known blockage to one or more renal arteries
• Patients with known condition that would increase the likelihood of vascular perforation, trauma, or dissection such as Marfan's syndrome, cystic medial necrosis, abdominal or thoracoabdominal aortic dissection, mycotic aneurysm, abdominal aneurysm, thoracoabdominal aneurysm, renal artery aneurysm, thoracic aneurysm involving the visceral region of the aorta, and severe calcification in the area of the renal arteries

Where it is running

• Erlanger Medical Center — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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