ISRCTN12291961已完成未知
HYDration and bicarbonate to prevent acute Renal injury after endovascular Aneurysm repair: pilot-feasibility randomized controlled study (HYDRA pilot trial)
niversity of Leicester0 个研究点目标入组 58 人开始时间: 2016年9月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 58
研究概览
简要总结
2018 Results article in https://pubmed.ncbi.nlm.nih.gov/29482973/ (added 10/03/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Those undergoing an elective endovascular infra-renal abdominal aortic aneurysm repair, for a non-ruptured or leaking aneurysm
- •2. Aged 18 years and over
- •3. Able to provide informed consent for the EVAR and participation in the study
排除标准
- •1. Emergency abdominal aortic aneurysm repair
- •2. Leaking or ruptured aneurysm
- •3. Age<18 years
- •4. Established cardiac failure with functional status >NYHA III (severe heart failure)
- •5. Allergy to contrast medium or sodium bicarbonate
- •6. Pregnancy or lactation (pregnancy test is standard practice at baseline)
- •7. Juxtarenal or suprarenal aneurysm
- •8. Solitary kidney
- •9. Administration of intra-venous or intra-arterial contrast <2 days prior to EVAR
- •10. Previous open AAA or iliac aneurysm repair
- •11. Surgery within 1 month before EVAR
- •12. Major trauma within 1 month before EVAR
- •13. Established metabolic or respiratory alkalosis 14. Patient receiving chemotherapy, radiotherapy or steroid therapy
- •15. Life expectancy less than 1 year
- •16. Patient undergoing renal dialysis for established renal failure
- •17. Patient receiving nephrotoxic medication for 48 hours prior to EVAR
- •18. Patient unwilling or unable to provide informed consent
- •19. Participation in other interventional clinical trial 1 month prior to commencing HYDRA-P
- •20. Established pulmonary oedema at baseline
- •21. Hyperventilation
- •22. Hypernatraemia
- •23. Systolic blood pressure exceeding 200mHg at baseline
- •24. Unable to understand and provide consent in English
研究者
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