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

Phase 1CompletedNCT01950923

Wake Forest University Health Sciences30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Kidney Tumor

Interventions

sildenafil citrateDRUG

Given PO

placeboOTHER

Given PO

therapeutic conventional surgeryPROCEDURE

Undergo standard robotic partial nephrectomy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 6 months

Secondary Outcomes

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.

Time frame: Baseline to up to 1 month

Change in proteinuria

Compared between the two study groups.

Time frame: Baseline to up to 3 months

Estimated blood loss

Compared between the two study groups.

Time frame: At 24 hours after RPN

Hemoglobin concentration

Compared between the two study groups.

Time frame: At 24 hours after RPN

Changes in blood pressure measurements

Compared between the two study groups.

Data from ClinicalTrials.gov

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