Relationship Between Degree of Hydration Measured With Bioelectrical Impedance Phase Angle Analysis, Oxidative Stress and Postoperative Complications, a Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,696
- 主要终点
- Perioperative change in hydration
研究概览
简要总结
Fluid is added during anesthesia and surgery to maintain and balance the dynamic hemodynamics during a surgical procedure. Excess fluid after surgery is strongly correlated with morbidity and mortality. Bioelectrical impedance analysis (BIA) measures the total body water. Increased knowledge of the degree of preoperative hydration and the perioperative course can contribute to active treatment and reduced morbidity.
Women and men ≥18 years of age who are to undergo gynecological or urological operations are included in the study. The purpose is to analyze the baseline status of the degree of hydration measured as the total body water and its components, and to monitor changes in these during a postoperative course, and to look for connections between these parameters and patient characteristics, laboratory data, type of surgery, type of anesthesia, care period and onset of postoperative symptoms and complications.
详细描述
Background Fluid is added during anesthesia and surgery to maintain and balance the dynamic hemodynamics during a surgical procedure. The explanation for a positive fluid balance correlating with an unfavorable postoperative course is believed to be an extracellular volume expansion. Excess fluid after surgery is strongly correlated with morbidity and mortality. Increased knowledge of the degree of preoperative hydration and the perioperative course can contribute to active treatment and reduced morbidity.
Bioelectrical impedance analysis (BIA) measures the total body water expressed as a percentage of fat-free body mass. In connection with surgery and a perioperative course, there are few studies that have examined shifts in the body's fluid content with BIA.
The purpose of the study is to analyze the baseline status of the degree of hydration measured as the total body water and its components, and to monitor changes in these during a postoperative course, and to look for connections between these parameters and patient characteristics, laboratory data, type of surgery, type of anesthesia, care period and onset of postoperative symptoms and complications.
Overall hypothesis The degree of postoperative increase in the degree of hydration correlates with postoperative symptoms and complications.
Secondary hypotheses
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
- •Women and men ≥18 years of age who are to undergo gynecological or urological operations under general anesthesia, regional anesthesia, sedation or local anesthesia
- •Women and men who have given informed consent to participate in the study
排除标准
- •Patients with pacemakers or implanted defibrillators (ICDs)
- •Pregnant women with intrauterine viable pregnancy where the pregnancy should not be terminated
- •Disabled patients who can not stand on the scales
- •Patients with one hand or foot missing
- •Patients on dialysis due to kidney failure
- •Patients who are unable to understand the meaning of the study and provide informed consent
结局指标
主要结局
Perioperative change in hydration
时间窗: Preoperative on day of surgery and postoperative daily during hospital stay up to 30 days after surgery
Degree of hydration measured by bioelectrical impedance analysis
次要结局
- Postoperative symptoms(Day of surgery until 8 week postoperatively)
- Postoperative complications(Day of surgery until 8 week postoperatively)
- Duration of hospital care(Day of surgery until 8 weeks postoperatively)
- Precision of bioimpedance analysis of total body water in test-retest measurements.(Two repeated measurements preoperatively (less than 10 minutes))
- Precision of bioimpedance analysis of intracellular water in test-retest measurements.(Two repeated measurements preoperatively (less than 10 minutes))
- Precision of bioimpedance analysis of extracellular water in test-retest measurements.(Two repeated measurements preoperatively (less than 10 minutes))
- Precision of bioimpedance analysis of phase angel in test-retest measurements.(Two repeated measurements preoperatively (less than 10 minutes))
研究者
Preben Kjolhede, MD, professor
Professor
University Hospital, Linkoeping