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The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

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ClinicalTrials.gov Identifier: NCT00743106
Recruitment Status : Terminated (Executive committee determined to close study after interim analysis.)
First Posted : August 28, 2008
Results First Posted : October 31, 2016
Last Update Posted : April 12, 2018
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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.


Condition or disease Intervention/treatment Phase
Partial Nephrectomy Drug: Fenoldopam Drug: Placebo Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Fenoldopam on Renal Function in Solitary Partial Nephrectomy Surgery
Study Start Date : September 2002
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Fenoldopam
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Comparator
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: 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.
Drug: Fenoldopam
Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours



Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743106


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

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00743106     History of Changes
Other Study ID Numbers: 5508
First Posted: August 28, 2008    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: April 12, 2018
Last Verified: April 2018

Keywords provided by The Cleveland Clinic:
nephrectomy
fenoldopam
atrophic minimally functioning kidney

Additional relevant MeSH terms:
Fenoldopam
Antihypertensive Agents
Vasodilator Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs