The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

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

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.

Study Overview

• Status: Terminated
• Conditions: Partial Nephrectomy
• Intervention / Treatment: Drug: Placebo; Drug: Fenoldopam

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
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clnic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glomerular Filtration Rate (GFR) Percentage of Change From Baseline	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.	percentage of change from baseline to post-operatively day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Creatinine (mg/dL)	assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on postoperative day 1, 2, 3, 4)	"immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4"

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Jerome O'Hara, MD, The Cleveland Clinic; Study Chair: Daniel I Sessler, MD, Cleveland Clnic

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: August 26, 2008
• First Submitted That Met QC Criteria: August 27, 2008
• First Posted (Estimate): August 28, 2008

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 18, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: nephrectomy; fenoldopam; atrophic minimally functioning kidney
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Vasodilator Agents; Dopamine Agonists; Dopamine Agents; Fenoldopam
• Other Study ID Numbers: 5508