Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
-
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.
-
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.
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To measure between-group differences in estimated blood loss and hemoglobin concentration at 24 hours following RPN.
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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.
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To describe between-group variations in vasopressor support or intravenous fluid requirements during the operative procedure.
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To compare overall complication rates (within 90 days postoperatively) between groups.
-
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (sildenafil citrate) Patients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy. |
Drug: sildenafil citrate
Given PO
Other Names:
Procedure: therapeutic conventional surgery
Undergo standard robotic partial nephrectomy
|
| Placebo Comparator: Arm II (placebo) Patients receive placebo PO before the initiation of standard robotic partial nephrectomy. |
Other: placebo
Given PO
Other Names:
Procedure: therapeutic conventional surgery
Undergo standard robotic partial nephrectomy
|
Outcome Measures
Primary Outcome Measures
- Accrual rate [Up to 6 months]
Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.
- Retention rate [Up to 3 months]
Retention will be assessed by whether or not the patient attends his or her 1 and 3 month postoperative visits.
- Participation rate [Up to 6 months]
Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.
Secondary Outcome Measures
- Change in GFR [Baseline to up to 1 month]
Regression analysis will be used; the change will be modeled, with adjustment for baseline GFR, to assess difference in the two study groups.
- Change in proteinuria [Baseline to up to 3 months]
Compared between the two study groups.
- Estimated blood loss [At 24 hours after RPN]
Compared between the two study groups.
- Hemoglobin concentration [At 24 hours after RPN]
Compared between the two study groups.
- Changes in blood pressure measurements [Baseline to up to 2 days after RPN]
Compared between the two study groups.
- Vasopressor support requirements during the operative procedure [During RPN]
Compared between the two study groups.
- Intravenous fluid requirements during the operative procedure [During RPN]
Compared between the two study groups.
- Overall complication rates [Up to 90 days after RPN]
Compared between the two study groups.
- Preliminary effect size of sildenafil citrate on change in GFR [At 3 months]
Eligibility Criteria
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])
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Ashok Hemal, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00021729-1
- NCI-2013-00988
- P30CA012197