A Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of Sildenafil (REVATIO®) in Cardiac Surgery

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of the study are the following:

• To evaluate the pharmacokinetic profile of Sildenafil in cardiac surgery patients at risk of acute kidney injury

• To determine the safety and tolerability of Sildenafil in cardiac surgery patients at risk of acute kidney injury

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leicester
• Collaborator: British Heart Foundation
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

1. Adult cardiac surgery patients (>18 years) undergoing cardiac surgery with moderately hypothermic CPB (32-34°C) and blood cardioplegia

2. Identified as representing a high risk group for acute kidney injury using a modified risk score based on the variables of Age, Sex, BMI, Smoking Status, NHYA class, Previous Operations, Peripheral Vascular Disease, Diabetes, Hypertension, Pre-operative Haemoglobin level, Pre-operative eGFR, Operative Priority, Operation Type, Ejection Fraction and Presence of Pre-Operative Critical Events.

3. Female subjects of childbearing potential are not to be pregnant (to be confirmed by urine human chorionic gonadotropin pregnancy test prior to dosing). Women are considered not to be of childbearing potential if they have been surgically sterilised (eg, tubal ligation, oophorectomy or hysterectomy) or are postmenopausal (defined as serum follicle-stimulating hormone level of ≥30 IU/mL) in the absence of hormone replacement therapy and complete absence of menses for at least 24 consecutive months.

Exclusion Criteria:

1. Emergency or salvage procedure

2. Ejection fraction <30%

3. CKD Stage 5, defined as eGFR<15ml/min or renal replacement therapy.

4. Administration of potent CYP 3A4 inhibitors within 1 month prior to study participation (e.g. HIV protease inhibitors, imidazole antifungals and erythromycin, please see Appendix 1 for a full list of prohibited medications).

5. Administration of nitrate medicines (e.g. glyceryl trinitrate within 24 hours of surgery.

6. Any ongoing malignancy, or prior malignancy that currently requires treatment.

7. Patients allergic to any other PDE-5 Inhibitor

8. Patients who are participating in another interventional clinical study

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