Pharmacokinetic profile, safety and tolerability of Sildenafil (REVATIO®) in cardiac surgery patients with chronic kidney disease

Phase 1

Completed

• Conditions: Cardiac surgery patients with chronic kidney disease; Urological and Genital Diseases; Chronic kidney disease

• Registration Number: ISRCTN37719011
• Lead Sponsor: niversity of Leicester (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-10
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Adult cardiac surgery patients (>16 years and <80 years) undergoing cardiac surgery with moderately hypothermic cardiopulmonary bypass (CPB) (32-34°C) and blood cardioplegia
2. eGFR >15 and <90ml/min (International classification of Chronic Kidney Disease, CKD, Stage 2-4)

Exclusion Criteria

1. Emergency or salvage procedure
2. Ejection fraction <30%
3. CKD Stage 1, defined as eGFR>90ml/min
4. CKD Stage 5, defined as eGFR<15ml/min or renal replacement therapy
5. Administration of potent CYP 3A4 inhibitors within 1 month prior to study participation
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified