The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

Partial Nephrectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00743106
• Other study ID #: 5508
• Status: Terminated
• Phase: N/A
• Start date: September 2002
• Est. completion date: February 2010

Study information

• Verified date: September 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 90
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Partial Nephrectomy

Intervention

Drug:
• Fenoldopam
Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours
• Placebo
Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery

Locations

Country	Name	City	State
United States	Cleveland Clnic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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"