The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

NeuroTherapia, Inc.

Status: Terminated

Conditions: Partial Nephrectomy

Treatments: Drug: Placebo; Drug: Fenoldopam

Study type: Interventional

Funder types: Other

Identifiers

NCT00743106

5508

Details and patient eligibility

About

This trial will study the effects of fenoldopam on renal function in patients who have a single kidney undergoing surgery to remove part of that kidney secondary to renal cell carcinoma. The investigators will monitor and evaluate throughout the perioperative course the kidney function. Normally kidney function is predicted to show a worsening followed by an improvement after surgery.

The investigators want to specifically identify if the use of fenoldopam lessens the injury to the kidney with this surgery.

Full description

Prospective, randomized, blinded study-dividing patients into one of two groups: fenoldopam or placebo. The infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.Study time period will be approximately six weeks from the date of surgery. Specifically, the following pre- and post operative laboratory results will be recorded if available: . Basic metabolic panel - pre-op, post op days 1, 2, 3, 4, and 6 weeks

• Serum osmolality, urine osmolality, urine sodium - pre-op, post op days 1, 3
• Glomerular filtration rate - pre-op, post op days 1, 3, and 6 weeks

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have a solitary kidney and present for a partial nephrectomy
• Patients who have one atrophic minimally functioning kidney and present for partial nephrectomy on the other kidney

Exclusion criteria

• History of current renal disease beyond the diagnosis of renal malignancy
• Insulin dependent diabetes mellitus, myocardial infarction without subsequent coronary artery bypass or angioplasty
• History of congestive heart failure, renovascular occlusion greater than 45 minutes or less than 15 minutes, greater than one half of the solitary kidney resected
• A major perioperative complication that would potentially affect postoperative renal function (myocardial infarction, congestive heart failure, pulmonary embolus, massive hemorrhage and hypotension, ureteral obstruction or vascular thrombosis), and evidence of nephrotoxicity due to antibiotics

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Placebo Comparator

Placebo Comparator group

Description:

Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours

Treatment:

Drug: Placebo

Fenoldopam Comparator

Active Comparator group

Description:

Fenoldopam (0.1 \~g/kg/min)infusion will commence after placing the patient in a lateral/flex position during the operation. The infusion will continue for a total of 24 hours.

Treatment:

Drug: Fenoldopam