ISRCTN18386427已完成2 期
The effect of sildenafil (REVatio®), a PDE-5 inhibitor, on post cardiac surgery acute kidney injury: a randomised, placebo-controlled phase IIb clinical trial: The REVAKI-2 Trial
niversity of Leicester (UK)0 个研究点目标入组 129 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
研究概览
简要总结
2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32245569 results (added 16/04/2020) 2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30364431/ (added 17/08/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35729178/ (added 07/11/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Adult cardiac surgery patients (>18 years) 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; a predicted risk score of 22% equates to a positive predicted value for developing AKI of >55%.
- •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.
- •1. Adult cardiac surgery patients (>18 years) 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; a predicted risk score of 22% equates to a positive predicted value for developing AKI of >55%.
排除标准
- •1. Emergency or salvage procedure
- •2. Ejection fraction <20%
- •3. CKD Stage 5, defined as eGFR<15ml/min (as per the Modified diet in Renal Disease formula ) or renal replacement therapy.
- •4. Patients with a pre-existing sepsis or organ injury defined as documented sepsis, acute kidney injury, acute lung injury, myocardial infarction, low cardiac output, liver injury, stroke or pancreatitis within 5 days of surgery.
- •5. Administration of potent CYP 3A4 inhibitors within 1 month prior to study participation (e.g. HIV protease inhibitors, imidazole antifungals and erythromycin,
- •6. Administration of nitrate medicines (e.g. glyceryl trinitrate) within 24 hours of surgery.
- •7. Patients allergic to any other PDE-5 Inhibitor.
- •8. Patients who are participating in another interventional clinical study.
- •9. 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.
- •10. Any ongoing malignancy or prior malignancy that currently requires treatment.
- •11. Female subjects of childbearing potential are not to be pregnant.
- •12. Cardiac surgery patients (<18 years) undergoing cardiac surgery with cardiopulmonary bypass and cardioplegic arrest.
- •13. Severe hepatic impairment.
- •14. Severe hypotension (blood pressure < 90/50 mmHg) on the day prior to surgery.
- •15. Administration of the guanylate cyclase stimulators, such as riociguat.
- •16. Unable, in the opinion of the investigator, or unwilling to give informed consent.
- •1. Emergency or salvage procedure
- •2. Ejection fraction <20%
- •3. CKD Stage 5, defined as eGFR<15ml/min (as per the Modified diet in Renal Disease formula ) or renal replacement therapy.
- •4. Patients with a pre-existing sepsis or organ injury defined as documented sepsis, acute kidney injury, acute lung injury, myocardial infarction, low cardiac output, liver injury, stroke or pancreatitis within 5 days of surgery.
- •5. Administration of potent CYP 3A4 inhibitors within 1 month prior to study participation (e.g. HIV protease inhibitors, imidazole antifungals and erythromycin,
- •6. Administration of nitrate medicines (e.g. glyceryl trinitrate) within 24 hours of surgery.
- •7. Patients allergic to any other PDE-5 Inhibitor.
- •8. Patients who are participating in another interventional clinical study.
- •9. 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.
- •10. Any ongoing malignancy or prior malignancy that currently requires treatment.
- •11. Female subjects of childbearing potential are not to be pregnant
研究者
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