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The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

This study has been terminated.
(Executive committee determined to close study after interim analysis.)
Information provided by (Responsible Party):
The Cleveland Clinic Identifier:
First received: August 26, 2008
Last updated: September 13, 2016
Last verified: September 2016

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.

Condition Intervention
Partial Nephrectomy
Drug: Fenoldopam
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Fenoldopam on Renal Function in Solitary Partial Nephrectomy Surgery

Resource links provided by NLM:

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Glomerular Filtration Rate (GFR) Percentage of Change From Baseline [ Time Frame: percentage of change from baseline to post-operatively day 3 ]
    Our intended primary analysis was to assess the effect of fenoldopam vs placebo on the GFR at post-operative day (POD) 3 with an analysis of covariance adjusting for the baseline GFR. However, because the intervention-by-baseline GFR interaction using GFR at POD 3 as the outcome was significant (P ¼ .006), the analysis of covariance was not valid. We, therefore, used the GFR percentage of change from baseline to POD 3 as the primary outcome.

Secondary Outcome Measures:
  • To Evaluate the Effects of Lateral Flexion on Patient Hemodynamic Changes as Well as EKG Changes in the Operating Room. [ Time Frame: 6 weeks post-operatively ]

Enrollment: 90
Study Start Date: September 2002
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours
Drug: Placebo
Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery
Active Comparator: I
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.
Drug: Fenoldopam
Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00743106

United States, Ohio
Cleveland Clnic
ClevelAnd, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Principal Investigator: Jerome O'Hara, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD Cleveland Clnic
  More Information

Responsible Party: The Cleveland Clinic Identifier: NCT00743106     History of Changes
Other Study ID Numbers: 5508
Study First Received: August 26, 2008
Results First Received: June 20, 2016
Last Updated: September 13, 2016

Keywords provided by The Cleveland Clinic:
atrophic minimally functioning kidney

Additional relevant MeSH terms:
Antihypertensive Agents
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 24, 2017