Clinical trial NCT00743106: The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery
Official title: The Effect of Fenoldopam on Renal Function in Solitary Partial Nephrectomy Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Partial Nephrectomy
Keywords: nephrectomy
fenoldopam
atrophic minimally functioning kidney
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Glomerular Filtration Rate (GFR) Percentage of Change From Baseline
timeFrame: percentage of change from baseline to post-operatively day 3
Secondary outcomes:
measure: Postoperative Creatinine (mg/dL)
timeFrame: "immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4"
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clnic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Jerome O'Hara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clnic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
References: