Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT00743106
Status:
TERMINATED
Last Update Posted:
2018-09-19
First Post:
2008-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery
Sponsor:
The Cleveland Clinic
Organization:
Study Overview
Official Title:
The Effect of Fenoldopam on Renal Function in Solitary Partial Nephrectomy Surgery
Status:
TERMINATED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Executive committee determined to close study after interim analysis.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
The investigators want to specifically identify if the use of fenoldopam lessens the injury to the kidney with this surgery.
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
* 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: