Predictive Value of Surgical Stress Markers for 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
- 150
- 试验地点
- 1
- 主要终点
- Predictive Value of Postoperative Albumin Decrease in Terms of Surgical Stress and Postoperative Complications
研究概览
简要总结
The aim of this study is to evaluate the predictive value of albumine, C-reactive protein (CRP), procalcitonin, and lactates in terms of surgical stress and postoperative complications. These biomarkers will be measured from the day before surgery until postoperative day four in patients undergoing major surgery. Major surgery was defined as esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal procedures including an organ resection for benign or malignant disease and lasting more than 2 hours.
详细描述
This prospective study was conducted at the Department for Visceral Surgery at the University Hospital of Lausanne Switzerland (CHUV) between February and December 2015 (NCT02356484). The study was approved by the Institutional Review Board (No. 367/15), and all patients provided written consent prior to surgery. Inclusion criteria were age >18 years, and elective major abdominal surgery-defined as an operative procedure with anticipated duration ≥2 hours.17 Perioperative care closely adhered to recently published enhanced recovery guidelines (http://erassociety.org.loopiadns.com/guidelines/list-of-guidelines). Standardised fluid administration was followed by advanced haemodynamic monitoring to avoid intraoperative fluid overload. According to the clinical care pathway, intravenous fluid was typically discontinued the morning after surgery.
Biological markers Serum levels of albumin, CRP, PCT and lactate (LCT) were perioperatively measured in a fasting state, Following standardised institutional guidelines. Blood samples were drawn the day before surgery, the day of surgery (4-6 hours after the end of the operation) and on the first, second and third postoperative day. As Baseline values tend to show large variations especially for albumin,4 10 we considered that a dynamic value (difference between two time-points) might be more informative than a snapshot value. Several values based on preoperative and postoperative concentrations were thus calculated for each marker (ie, Δ Max: maximal difference between the preoperative and postoperative values; Δ POD 0: difference of concentration on POD -1 and POD 0; Δ POD 1: difference of concentration on POD-1 and POD 1).
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
- 是
入选标准
- •Patients over 18 years old
- •Patients undergoing esophagus, gastric, liver, pancreas, endocrine, retroperitoneal, or colorectal surgery
- •Operation time more than 2 hours
- •Operation including an organ resection for benign or malignant disease
排除标准
- •Immunosuppressive therapy
- •Cognitive impairment or language comprehension problems
- •Absence of the consent form prior to first blood sample
结局指标
主要结局
Predictive Value of Postoperative Albumin Decrease in Terms of Surgical Stress and Postoperative Complications
时间窗: Albumin preoperatively (day -1) and postoperatively (day 1) after surgery
Delta albumin (g/l) before (day -1) and immediately (day 1) after surgery as a predictor of postoperative complications (until 30 days post surgery)
次要结局
未报告次要终点
研究者
Nicolas DEMARTINES
Professor
University of Lausanne Hospitals
