Study to determine the pharmacokinetic profile, safety and tolerability of Sildenafil in cardiac surgery

Phase 1

Completed

• Conditions: Circulatory System; Topic: Cardiovascular, Renal and Urogenital; Subtopic: Cardiovascular (all Subtopics), Renal and Urogenital (all Subtopics); Disease: Renal, Cardiac Surgery

• Registration Number: ISRCTN06134609
• Lead Sponsor: niversity of Leicester (UK)

Brief Summary

2017 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5346869/

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-24
• Study Completion: 2014-04-09
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

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

Inclusion Criteria

1. Adult cardiac surgery patients (>18 years and <80 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.
3. Female subjects of childbearing potential are not to be pregnant (to be confirmed by urine human chorionic gonadotropin pregnancy test). 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.
Target Gender: Male & Female; Upper Age Limit 80 years ; Lower Age Limit 18 years

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Plasma levels of Sildenafil; Timepoint(s): Blood samples for pharmacokinetic analysis at the time points outlined below:<br> 1. Prior to the start of the bolus infusion (0 min)<br> 2. End of bolus Sildenafil infusion (10 min)<br> 3.15 minutes, 30 minutes and 45 minutes post bolus infusion (25 min, 40 min and 55 min)<br> 4. 2hrs post bolus infusion or end of cardiopulmonary bypass, whichever is the latest (2 hrs 10 min)<br> 5. Return to CICU (4 hrs 10 min)<br> 6. 6 hrs post bolus infusion (6 hrs 10 min)<br> 7. 12 hrs post infusion (12 hrs 10 min)<br> 8. Day 1 (24 hrs post infusion)<br> 9. Day 2 (48 hrs post-infusion)<br>

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration