Does Hemodynamic Optimization During and After Colorectal Surgery Result in Improved Intestinal Perfusion, Sustained Intestinal Barrier and Improved Postoperative Recovery?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Peak Value of I-FABP
研究概览
简要总结
58 patients undergoing surgery of the large bowel are divided into two groups. The control group will receive standard care. The intervention group will receive standard care plus optimization of the blood circulation based on in- or decrease of the output of the heart. Between group differences are measured primarily by markers of intestinal damage in plasma and urine. Also CO2 pressure in the stomach lumen is measured (reflecting blood supply to the gut).
The investigators hypothesize that the intervention group will have less intestinal damage, improved blood supply to the bowel and improved recovery of the operation compared to the control group.
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
- •All patients undergoing elective colorectal surgery with anastomosis;
- •Minimum age 18 years;
- •Giving informed consent.
排除标准
- •Other causes of intestinal damage: eg. IBD, occlusive disease;
- •Steroid use;
- •Esophageal varices and other esophageal disease;
- •Aortic valve disease.
研究组 & 干预措施
Goal-directed fluid optimization
Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
干预措施: Goal-directed fluid optimization (Procedure)
Regimen based on expertise anaesthesist
Fluid regimen based on expertise anaesthesist
干预措施: Regimen based on expertise anaesthesist (Other)
结局指标
主要结局
Peak Value of I-FABP
时间窗: 1 hour postoperatively
Intestinal-Fatty Acid Binding Protein (a marker of intestinal damage) is measured in plasma. The primary outcome measure is the difference in peak values of I-FABP between the control group and the intervention group.
次要结局
- Average Intraoperative CO2 Gap(Average intraoperative CO2 gap)