Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer

Study Overview
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Brief Summary
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This randomized pilot clinical trial studies sildenafil citrate before surgery in improving kidney function in patients with kidney cancer. Sildenafil citrate may help protect the kidney from the side effects of surgery and improve kidney function after surgery.

Detailed Description
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PRIMARY OBJECTIVES: I. To assess accrual, retention, and participation rates for patients receiving sildenafil (sildenafil citrate) compared to placebo in patients undergoing robotic partial nephrectomy (RPN) for a suspected renal malignancy. SECONDARY OBJECTIVES: I. To evaluate individual alterations in glomerular filtration rate (GFR) at 24 hours, 48 hours and one month following RPN and compare these to the placebo group. II. To evaluate individual alterations in proteinuria at 24 hours, 48 hours, one month and three months following RPN and compare these to the placebo group. III. To measure between-group differences in estimated blood loss and hemoglobin concentration at 24 hours following RPN. IV. To describe individual changes in blood pressure measurements as noted in the preoperative holding area, throughout the procedure and in the post-anesthesia care unit. V. To describe between-group variations in vasopressor support or intravenous fluid requirements during the operative procedure. VI. To compare overall complication rates (within 90 days postoperatively) between groups. VII. To obtain a preliminary effect size of sildenafil on change in GFR at three months following RPN. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive sildenafil citrate orally (PO) before the initiation of standard robotic partial nephrectomy. ARM II: Patients receive placebo PO before the initiation of standard robotic partial nephrectomy. After completion of study treatment, patients are followed up at 1 and 3 months.

Official Title
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Sildenafil Prior to Robotic Partial Nephrectomy to Improve Postoperative Renal Function: A Randomized, Placebo-Controlled Pilot Study

Conditions
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Kidney Tumor

Intervention / Treatment
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* Drug: sildenafil citrate
* Other: placebo
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are scheduled to undergo robotic partial nephrectomy for suspected renal malignancy Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Patients with a history of coronary artery disease (including history of myocardial infarction or cardiac stents) or a history of inducible ischemic changes on any prior cardiac stress testing History of adverse reactions to any phosphodiesterase (PDE) inhibitor (PDE type 5 inhibitor [PDE5i]) Any patient currently taking a PDE5i will be asked to refrain from use for one week prior to their surgery; patients who have used a PDE5i within 72 hours of surgery will be excluded Pregnant women are excluded from this study Patients with only one kidney

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (sildenafil citrate)<br>Patients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy. | Drug: sildenafil citrate<br>* Given PO<br>* Other names: Viagra;Procedure: therapeutic conventional surgery<br>* Undergo standard robotic partial nephrectomy<br>|
| Placebo Comparator: Arm II (placebo)<br>Patients receive placebo PO before the initiation of standard robotic partial nephrectomy. | Other: placebo<br>* Given PO<br>* Other names: PLCB;Procedure: therapeutic conventional surgery<br>* Undergo standard robotic partial nephrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accrual rate | Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study. | Up to 6 months | 
| Retention rate | Retention will be assessed by whether or not the patient attends his or her 1 and 3 month postoperative visits. | Up to 3 months | 
| Participation rate | Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in GFR | Regression analysis will be used; the change will be modeled, with adjustment for baseline GFR, to assess difference in the two study groups. | Baseline to up to 1 month | 
| Change in proteinuria | Compared between the two study groups. | Baseline to up to 3 months | 
| Estimated blood loss | Compared between the two study groups. | At 24 hours after RPN | 
| Hemoglobin concentration | Compared between the two study groups. | At 24 hours after RPN | 
| Changes in blood pressure measurements | Compared between the two study groups. | Baseline to up to 2 days after RPN | 
| Vasopressor support requirements during the operative procedure | Compared between the two study groups. | During RPN | 
| Intravenous fluid requirements during the operative procedure | Compared between the two study groups. | During RPN | 
| Overall complication rates | Compared between the two study groups. | Up to 90 days after RPN | 
| Preliminary effect size of sildenafil citrate on change in GFR |  | At 3 months |