The Contribution of Liberal Fluid Therapy to Glycocalyx Shedding, Interstitial Edema and Fluid Accumulation During Moderate Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Change from preoperative serum concentration of Syndecan-1.
研究概览
简要总结
Goal-directed fluid therapy is one of the most accepted strategies in intraoperative fluid therapy, although potential fluid overload is a possible drawback. Fluid overload has recently been shown to cause damage to the glycocalyx and to increase extravasation of fluids into the interstitial space.
This study aims to determine whether liberal fluid administration during moderate surgery results in impairment to the endothelial glycocalyx and causes edema.
Participants will be randomized to receive either a liberal or restrictive fluid protocol with vasopressor support. The investigators will measure interstitial edema by clinical signs, pulmonary congestion by ultrasound, and extracellular water by bioimpedance. Impairment of glycocalyx will be estimated by measuring blood levels of shedding markers. In addition, wound healing and early postoperative outcome will be estimated by POMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for abdominoplasty.
- •American Society of Anesthesiologists Classification 1 or 2.
排除标准
- •Pregnancy.
结局指标
主要结局
Change from preoperative serum concentration of Syndecan-1.
时间窗: Two hours after completion of surgery.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Change from preoperative serum concentration of Heparan Sulfate.
时间窗: Two hours after completion of surgery.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Change from preoperative serum concentration of Sphingosine-1-Phosphate.
时间窗: Two hours after completion of surgery.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Early appearance of peripheral pitting edema.
时间窗: Two hours after completion of surgery.
Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.
Late appearance of peripheral pitting edema.
时间窗: During the first postoperative day.
Bilateral physical examination of the study participant's wrists and ankles, performed by a physician.
Late change in the percentage of Total Body Water and Extracellular Water.
时间窗: Two hours after completion of surgery.
Measured by bioimpedance using a commercially available device connected to the study participant.
Change from preoperative serum concentration of Hyaluronic Acid.
时间窗: Two hours after completion of surgery.
Measured using blood samples drawn from a peripheral vein of the study participant and analyzed in a laboratory.
Appearance of B-lines on lung ultrasonography.
时间窗: Two hours after completion of surgery.
Bilateral ultrasonography of the study participant's lungs, performed by a physician using two views: posterior and lateral.
Early change in the percentage of Total Body Water and Extracellular Water.
时间窗: Immediately after completion of surgery.
Measured by bioimpedance using a commercially available device connected to the study participant.
Postoperative Morbidity Survey (POMS) Score.
时间窗: During the first postoperative day.
Clinically evaluated by a physician for each study participant.
次要结局
- Change from preoperative body weight.(During the first postoperative day.)
- Volume of urine produced during the procedure.(Immediately after completion of surgery.)
- Early change from preoperative Cardiac Output.(Immediately after completion of surgery.)
- Early change from preoperative serum concentration of C-Reactive Protein.(Immediately after completion of surgery.)
- Late change from preoperative serum concentration of C-Reactive Protein.(Two hours after completion of surgery.)
- Early change from preoperative serum concentration of Lactate.(Immediately after completion of surgery.)
- Change from preoperative serum concentration of Creatinine.(Immediately after completion of surgery.)
- Change from preoperative Mean Arterial Blood Pressure.(Immediately after completion of surgery.)
- Change from preoperative serum concentration of Hemoglobin.(Immediately after completion of surgery.)
- Change from preoperative Heart Rate.(Immediately after completion of surgery.)
- Late change from preoperative Cardiac Output.(Two hours after completion of surgery.)
- Late change from preoperative serum concentration of Lactate.(Two hours after completion of surgery.)