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
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Placebo Comparator: Placebo Comparator
Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours
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.
Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours
- 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.
- 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 ]
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
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Jerome O'Hara, MD||The Cleveland Clinic|
|Study Chair:||Daniel I Sessler, MD||Cleveland Clnic|