NCT02174575撤回4 期
Effects of Different Inhalational Anesthetic Agents on the Incidence of Clinical and Subclinical Acute Kidney Injury After Liver Resection Surgery: a Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Postoperative acute kidney injury
研究概览
简要总结
- It has been shown that patients who undergo liver resection surgery are at high risk for postoperative acute kidney injury (AKI).
- Sevoflurane may increase the risk for postoperative AKI because of production of compound-A.
- Therefore, we have planned to investigate the effects of different anesthetic agents on postoperative renal function.
- Patients undergoing liver resection surgery are randomized into 2 groups.
- One of the groups receives sevoflurane and the other group receives desflurane.
- Blood and urine specimen are sampled both pre- and postoperatively, and several biomarkers are compared between the groups.
详细描述
- Design
- This is a randomized, observer-blinded, controlled trial.
- Study objectives and hypothesis
- The aim of this study is to prove the hypothesis that desflurane is safer than sevoflurane in terms of the association with postoperative acute kidney injury (AKI) after liver resection surgery.
- Inclusion and exclusion criteria
- Inclusion criteria: Forty adult patients (20 patients in each group) who are planned to undergo liver resection surgery are included.
- Exclusion criteria: Patients who undergo less invasive liver resection surgery under thoracoscopy or laparoscopy are excluded. Patients with chronic kidney disease, or allergic to any anesthetic agents used in the study (e.g., desflurane, sevoflurane, propofol, remifentanil, rocuronium) are also excluded.
- Outcome definition
- AKI is diagnosed based on RIFLE creatinine criteria within 72 hours postoperatively. Serum creatinine is measured preoperatively, on the day of the surgery, and 1st, 2nd, and 3rd postoperative days.
- Methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forty adult patients (20 patients in each group) who are planned to undergo liver resection surgery are included.
排除标准
- •Patients who undergo less invasive resection surgery under thoracoscopy or laparoscopy are excluded. Patients with chronic kidney disease, or allergic to any anesthetic agents used in the study are also excluded.
研究组 & 干预措施
Sevoflurane
Active Comparator
Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia.
干预措施: Sevoflurane (Drug)
Desflurane
Active Comparator
Patients are randomized into 2 groups (Desflurane group and Sevoflurane group) depending on the anesthetic agents administered during anesthesia.
干预措施: Desflurane (Drug)
结局指标
主要结局
Postoperative acute kidney injury
时间窗: within 72 hours postoperatively
Postoperative acute kidney injury is defined based on RIFLE creatinine criteria.
次要结局
- Urine IL-6 concentration(On the day of surgery and postoperative day 1)
- Urine NGAL concentration(On the day of surgery and postoperative day 1)
- Urine albumin concentration(On the day of surgery and postoperative day 1)
- Plasma NGAL concentration(On the day of surgery and postoperative day 1)
- Serum cystatin C concentration(On the day of surgery and postoperative day 1)
- Urine L-FABP concentration(On the day of surgery and postoperative day 1)
- Urine NAG concentration(On the day of surgery and postoperative day 1)
研究者
Koshi Makita, MD
Professor
Tokyo Medical and Dental University
研究点 (1)
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