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临床试验/NCT02356484
NCT02356484已完成不适用

Predictive Value of Surgical Stress Markers for Postoperative Complications: a Prospective Study

University of Lausanne Hospitals1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2015年2月最近更新:
适应症

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

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

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas DEMARTINES

Professor

University of Lausanne Hospitals

研究点 (1)

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