Perioperative Metabolic and Hormonal Aspects in Major Emergency Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Changes of cortisol
研究概览
简要总结
Emergency laparotomies, which most often is performed due to high risk disease (bowel obstruction, ischemia, perforation, etc.), make up 11 % of surgical procedures in emergency surgical departments, however, give rise to 80 % of all postoperative complications. The 30-day mortality rates in relation to these emergent procedures have been reported between 14-30 %, with even higher numbers for frail and older patients. The specific reasons for these outcomes are not yet known, however, a combination of preexisting comorbidities, acute illness, sepsis, and the surgical stress response that arise during- and after the surgical procedure due to the activation of the immunological and humoral system, is most likely to blame. The complex endocrinological response and consequences of this response to emergency surgery are sparsely reported in the literature.
The aim of this PHASE project is to evaluate and describe the temporal endocrine, endothelial and immunological changes after major emergency abdominal surgery, and to associate these changes with clinical postoperative outcomes.
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
- •Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
- •Major gastrointestinal surgery on the gastrointestinal tract (see intervention definition)
排除标准
- •Not capable of giving informed consent after oral and written information
- •Previously included in the trial
- •Elective laparoscopy
- •Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
- •Appendectomy +/- drainage or Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
- •Non-elective hernia repair without bowel resection.
- •Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
- •Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
- •Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma, esophageal pathology, pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract
结局指标
主要结局
Changes of cortisol
时间窗: Change from preoperative levels at postoperative day 5
Assessment of plasma cortisol (free and bound)
Changes of immunological biomarkers
时间窗: Change from preoperative levels at postoperative day 5
Assessment of: * plasma inflammatory interleukines incl. IL-1-alfa, IL-1beta, IL-6, IL-10 * plasma TNF-alfa * plasma TGF-beta
Number of patients with stress induced hyperglycemia
时间窗: Postoperative day 5
Assessment of: * Blood glucose, plasma c-peptide, HbA1C * plasma Glucagon-like peptide 1 (GLP-1)
Changes of plasma thyroid hormones
时间窗: Change from preoperative levels at postoperative day 5
Assessment of: * Thyropin-releasing hormone (TRH) * Thyroid-stimulating hormone (TSH) * Thyroid hormones (fT3, fT4, rT3)
Changes of syndecan-1
时间窗: Change from preoperative levels at postoperative day 5
Assessment of plasma syndecan-1
Changes of the central endocrine stress response
时间窗: Change from preoperative levels at postoperative day 5
Assessment of plasma corticotropin releasing hormone (CRH)
Changes of sE-selectin
时间窗: Change from preoperative levels at postoperative day 5
Assessment of plasma sE-selectine * sE-selectin * syndecan-1 * thrombomodulin * sVE-cadherin
Changes of the endothelial function
时间窗: Change from postoperative day 1 at postoperative day 5
Assessed with the non-invasive EndoPAT and expressed as the reactive hyperemia index
Changes of the periferal endocrine stress response
时间窗: Change from preoperative levels at postoperative day 5
Assessment of plasma adrenocorticotropic hormone (ACTH)
Changes of thrombomodulin
时间窗: Change from preoperative levels at postoperative day 5
Assessment of plasma thrombomodulin
Changes of sVE-cadherin
时间窗: Change from preoperative levels at postoperative day 5
Assessment of plasma sVE-cadherin
Changes of neuropeptides
时间窗: Change from preoperative levels at postoperative day 5
Assessment of plasma neuropeptides
次要结局
- Number of patients with major adverse cardiovascular events(365 days after surgery)
- Number of patients with postoperative non-cardiovascular complications(365 days after surgery)