The Effect of Sildenafil (Revatio®) on Post Cardiac Surgery Acute Kidney Injury (AKI): A Randomised, Placebo-controlled Clinical Trial: REVAKI 2 Trial

Phase 1

• Conditions: Post cardiac surgery acute kidney injury; MedDRA version: 18.1 Level: PT Classification code 10069339 Term: Acute kidney injury System Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-003259-24-GB
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-23
• Study Completion: 2018-09-20
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 129

Inclusion Criteria

1.Adult cardiac surgery patients (>18 years) and above undergoing cardiac surgery with cardiopulmonary bypass and cardioplegic arrest.
2.Identified as representing a high risk group for AKI using a modified AKI risk score equal or greater than 22%.
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 in the absence of hormone replacement therapy and complete absence of menses for at least 24 consecutive months.
4. Able, in the opinion of the investigator, and willing to give informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

Exclusion Criteria

1.Cardiac surgery patients (<18 years) undergoing cardiac surgery with cardiopulmonary bypass and cardioplegic arrest.
2. Emergency or salvage procedure
3.Ejection fraction <20%
4.CKD Stage 5, defined as eGFR<15ml/min or renal replacement therapy. (as per the Modified diet in Renal Disease formula ) or renal replacement therapy
5.Patients with a pre-existing sepsis or organ injury defined as documented sepsis, AKI, acute lung injury, myocardial infarction, low cardiac output, liver injury, stroke or pancreatitis within 5 days of surgery.
6.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).
7.Administration of nitrate medicines (e.g. glyceryl trinitrate within 24 hours of surgery.
8.Patients allergic to any other PDE-5 Inhibitor.
9.Any ongoing malignancy or prior malignancy that currently requires treatment.
10.Patients who are participating in another interventional clinical study.
11.Patients who have loss of vision in one eye due to non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether it is connected to previous PDE5 inhibitor exposure.
12.Risk of pregnancy
13. Unable, in the opinion of the investigator, or unwilling to give informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified