Clinical trial NCT01950923: Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer
Official title: Sildenafil Prior to Robotic Partial Nephrectomy to Improve Postoperative Renal Function: A Randomized, Placebo-Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Tumor
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accrual rate
timeFrame: Up to 6 months
measure: Retention rate
timeFrame: Up to 3 months
measure: Participation rate
timeFrame: Up to 6 months
Secondary outcomes:
measure: Change in GFR
timeFrame: Baseline to up to 1 month
measure: Change in proteinuria
timeFrame: Baseline to up to 3 months
measure: Estimated blood loss
timeFrame: At 24 hours after RPN
measure: Hemoglobin concentration
timeFrame: At 24 hours after RPN
measure: Changes in blood pressure measurements
timeFrame: Baseline to up to 2 days after RPN
measure: Vasopressor support requirements during the operative procedure
timeFrame: During RPN
measure: Intravenous fluid requirements during the operative procedure
timeFrame: During RPN
measure: Overall complication rates
timeFrame: Up to 90 days after RPN
measure: Preliminary effect size of sildenafil citrate on change in GFR
timeFrame: At 3 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Ashok Hemal
role: PRINCIPAL_INVESTIGATOR
References: