NCT00888641已完成1 期
A Pilot Study of Renal Hypothermia During Partial Nephrectomy
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- measures of renal function uCrCl be performed for estimation of renal function
研究概览
简要总结
Renal hypothermia may preserve renal function in patients who require partial nephrectomy. In preparation for a definitive randomized controlled trial this pilot study will assess feasibility and variance data to be used for sample size estimation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with a renal mass deemed amenable to an open partial nephrectomy regardless of stage or histology.
- •Bilateral renal function on radiographic imaging.
- •Willing to consent to randomization.
- •Willing to comply with study protocol.
排除标准
- •Anatomically or functionally solitary kidney
- •Multiple renal tumours
- •Bilateral renal tumours
- •Life expectancy < 3 months as deemed by treating physician
- •Age less than 18 years old
研究组 & 干预措施
Normothermia
No Intervention
After arterial clamping, no ice slush will be used
Hypothermia
Experimental
After arterial clamping, the kidney will be surrounded in ice slush for 10 minutes
干预措施: Hypothermia (Procedure)
结局指标
主要结局
measures of renal function uCrCl be performed for estimation of renal function
时间窗: 3 months
次要结局
- Post-operative complication(3 months)
研究者
研究点 (1)
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