Inflammation and Organ Impact During Hepatic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Ischemic Intestinal Damage
研究概览
简要总结
Monitoring of inflammatory substances (such as interleukins, CRP, albumine), and markers of organ dysfunction (such as creatinine, proenkephaline, amylase, troponine, IFABP and lactate) during elective liver resection. The study also includes monitoring of hemodynamic parameters, blood loss and postoperative complications. Results are to be used för power calculation for future trials.
详细描述
During hepatic surgery, blood and urine samples will be obtained at 3 times during surgery, at 3 h after resection of liver, at 24 h after resection of liver and at post operative day 2, and subsequntly analyzed for the above mentioned substances. Routine labs will be monitored until patient is discharged from hospital. During surgery, hemodynamic parameters will be monitored by Picco calculations. Urine output and blood loss will be registred.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ASA I-III Patient has given informed consent to participate in study.
排除标准
- •preoperative kidney failure (E-GFR >30), current infection treatment with corticosteroids coagulopathy surgical or anatomical conditions that makes patient unsuitable for participation (for example reoperation, need of vascular bypass, single tumor)
结局指标
主要结局
Ischemic Intestinal Damage
时间窗: from day of surgery until 24-48 hours postoperatively
rise in IFABP in nanograms/ml,
Kidney injury
时间窗: from day of surgery until 24-48 hours postoperatively
NAG units/g increase in urine.
Intestinal Bacterial Transloction
时间窗: from day of surgery until 24-48 hours postoperatively
Rise in D-lactate in micromol/ml
次要结局
- Description of Inflammatory Response(from day of surgery and approximately 1 week onwards)
研究者
Ellinor Wisén
MD, consultant
Sahlgrenska University Hospital