The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Partial Nephrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Comparator

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Fenoldopam Comparator

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.

Group Type ACTIVE_COMPARATOR

Fenoldopam

Intervention Type DRUG

Fenoldopam (0.1 \~g/kg/min)started during surgery and lasting for a total of 24 hours

Interventions

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Fenoldopam

Fenoldopam (0.1 \~g/kg/min)started during surgery and lasting for a total of 24 hours

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No