The Effect of Fenoldopam in Solitary Partial Nephrectomy Surgery

NCT00743106 | Terminated Results

• 1 other identifier: 5508
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial Nephrectomy

Keywords

nephrectomy; fenoldopam; atrophic minimally functioning kidney

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Postoperative Creatinine (mg/dL)

  "immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4"

Study Arms (2)

Placebo Comparator

PLACEBO COMPARATOR

Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours

Drug: Placebo

Fenoldopam Comparator

ACTIVE 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

Interventions

Fenoldopam DRUG

Fenoldopam (0.1 \~g/kg/min)started during surgery and lasting for a total of 24 hours

Fenoldopam Comparator

Placebo DRUG

Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clnic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Esezobor CI, Bhatt GC, Effa EE, Hodson EM. Fenoldopam for preventing and treating acute kidney injury. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD012905. doi: 10.1002/14651858.CD012905.pub2.

  PMID: 39607014 DERIVED

MeSH Terms

Interventions

Fenoldopam

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jerome O'Hara, MD
• Organization: Cleveland Clinic Foundation

oharaj@ccf.org

216-444-8278

Study Officials

• Jerome O'Hara, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• Daniel I Sessler, MD

  Cleveland Clnic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: September 1, 2002
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: September 19, 2018
• Results First Posted: October 31, 2016

Record last verified: 2018-09

Locations

US (1)