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The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

This study has been terminated.
(Executive committee determined to close study after interim analysis.)
Sponsor:
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT00743106
First received: August 26, 2008
Last updated: March 23, 2010
Last verified: March 2010
  Purpose

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 Intervention
Partial Nephrectomy
Drug: Fenoldopam
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Fenoldopam on Renal Function in Solitary Partial Nephrectomy Surgery

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • To determine if fenoldopam provides a renal protective benefit in this group of surgical patients when compared to placebo. [ Time Frame: 6 weeks post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: September 2002
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
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
Other Name: placebo
Active Comparator: I
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
Other Name: 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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743106

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

No publications provided

Responsible Party: Jerome O'Hara, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00743106     History of Changes
Other Study ID Numbers: 5508
Study First Received: August 26, 2008
Last Updated: March 23, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Outcomes Research Consortium:
nephrectomy
fenoldopam
atrophic minimally functioning kidney

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

ClinicalTrials.gov processed this record on November 20, 2014