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Executive committee determined to close study after interim analysis.
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator | Placebo Comparator | Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenoldopam | Drug | Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours |
|
| 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 |
| 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" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome O'Hara, MD | The Cleveland Clinic | Principal Investigator |
| Daniel I Sessler, MD | Cleveland Clnic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clnic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39607014 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery |
| FG001 | Fenoldopam | 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. Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery |
| BG001 | Fenoldopam |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage change | percentage of change from baseline to post-operatively day 3 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo (0.9% Nacl)infusion beginning during surgery and lasting for up to 24 hours Placebo: Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerome O'Hara, MD | Cleveland Clinic Foundation | 216-444-8278 | oharaj@ccf.org |
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| ID | Term |
|---|---|
| D018818 | Fenoldopam |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo infusion(0.9% Nacl) beginning during surgery and lasting for up 24 hours post surgery |
|
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.
Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| GFR | Mean | Standard Deviation | mL/min |
|
| creatinine | Median | Inter-Quartile Range | mg/dL |
|
| Fenoldopam |
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. Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours |
|
|
|
| Secondary | Postoperative Creatinine (mg/dL) | assessed the effect of fenoldopam on creatinine over time (immediately postoperatively and on postoperative day 1, 2, 3, 4) | Posted | Mean | Standard Error | mg/dL | "immediately postoperative, postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4" |
|
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Fenoldopam | 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. Fenoldopam: Fenoldopam (0.1 ~g/kg/min)started during surgery and lasting for a total of 24 hours | 0 | 42 | 0 | 42 |
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| postoperative day 2 |
|
| postoperative day 3 |
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| postoperative day 4 |
|