EUCTR2015-003073-15-GB进行中（未招募）1 期
HYDration and bicarbonate to prevent acute Renal injury after endovascular Aneurysm repair: pilot-feasibility randomized controlled study (HYDRA pilot trial) - HYDRA-P
Research Governance, University of Leicester0 个研究点目标入组 58 人开始时间: 2019年3月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients who:
- •1. Undergo an elective endovascular infra-renal abdominal aortic aneurysm repair, for a non-ruptured or leaking aneurysm
- •2. Are above the age of 18 years
- •3. Are able to provide informed consent for the EVAR and participation in the study.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
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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