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The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

Information source: Outcomes Research Consortium
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Partial Nephrectomy

Intervention: Fenoldopam (Drug); Placebo (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Outcomes Research Consortium

Official(s) and/or principal investigator(s):
Jerome O'Hara, MD, Principal Investigator, Affiliation: The Cleveland Clinic
Daniel I Sessler, MD, Study Chair, Affiliation: Cleveland Clnic

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.

Clinical Details

Official title: The Effect of Fenoldopam on Renal Function in Solitary Partial Nephrectomy Surgery

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: To determine if fenoldopam provides a renal protective benefit in this group of surgical patients when compared to placebo.

Secondary outcome: To evaluate the effects of lateral flexion on patient hemodynamic changes as well as EKG changes in the operating room.

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Cleveland Clnic, ClevelAnd, Ohio 44195, United States
Additional Information

Starting date: September 2002
Last updated: March 23, 2010

Page last updated: August 23, 2015

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