跳至主要内容
临床试验/NCT03997721
NCT03997721已完成不适用

Pathophysiology of Perioperative Fluid Management in Patients Un-dergoing High Risk Emergency Laparotomy, a Prospective Descriptive Cohort Study

Copenhagen University Hospital, Hvidovre1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2019年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
The fluid distribution, during the early perioperative period (≤ 5 days), in patients with intestinal perforation versus intestinal obstruction versus postoperative complications with peritonitis.

研究概览

简要总结

Pathophysiology of perioperative fluid management in patients undergoing emergency laparotomy.

详细描述

In critically ill patients and patients undergoing major surgery, the combination of internal fluid shifts and fluid retention resulting in extravascular fluid accumulation and postoperative organ dysfunctions, complicates perioperative fluid management and influences patient outcome.

Changes in extravascular volume after surgery have been much debated, studies in major surgery suggest that extracellular volume expansion may correlate with intraoperative fluid administration, while other studies show the intravascular volume to be decreased after surgery.

Difficulty in obtaining accurate measurements of the fluid phases is recognized and despite years of research, perioperative extravascular volume changes have not been clarified in acute high-risk abdominal (AHA) surgery. It is essential to be able to identify and characterize the transition from necessary fluid resuscitation to harmful fluid volume accumulation, intra- as well as extravascular.

The present study seeks to investigate the perioperative fluid status and fluid shifts in patients undergoing AHA surgery, specifically focusing on intra- versus extra-vascular fluid status in patients with intestinal obstruction versus intestinal perforation.

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

  • Adults (18 years or over) undergoing emergency high-risk abdominal surgery for following abdominal pathology:
  • Perforated small intestine
  • Perforated large intestine
  • Perforated ulcer
  • Intestinal obstruction
  • Anastomotic leakage following elective surgery
  • Provided verbal and written informed consent
  • Must speak and understand the Danish language

排除标准

  • Appendectomies, cholecystectomies, negative diagnostic laparoscopies/laparotomies, herniotomies without bowel resections, sub-acute internal hernias after gastric bypass surgery, sub-acute surgery for inflammatory bowel diseases.
  • Primary surgery for intestinal ischemia, abdominal bleed
  • Emergency re-operations after elective surgery owing to intraabdominal bleeding, paralytic/obstructive ileus, intestinal ischemia
  • Reoperation owing to fascial separation with no other abdominal pathology identified and sub-acute colorectal cancer-surgery were excluded from the cohort. Sub-acute surgery was defined as surgery planned within 48 hours.
  • Traumas, gynecological, urogenital and other vascular pathology, pregnant patients.
  • Dementia and/or cognitive dysfunction (diagnosed).

结局指标

主要结局

The fluid distribution, during the early perioperative period (≤ 5 days), in patients with intestinal perforation versus intestinal obstruction versus postoperative complications with peritonitis.

时间窗: perioperative period

Intra vs. extra vascular. Stroke volume assessment, Bioimpedance measurements

次要结局

  • Correlation between fluid balance just prior to surgery and intraoperative need for vasopressor/inotropes administration.(Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day)
  • Impact of fluid distribution/fluid overload on preload dependency.(Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day)
  • Impact of fluid distribution/fluid overload on peripheral perfusion.(Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day)
  • Evaluate the relationship between fluid overload and mortality rate in patients undergoing emergency laparotomy.(Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day)
  • Association between pre- to postoperative changes in volume status and perioperative fluid volume administration, in patients with intestinal perforation versus intestinal obstruction versus postoperative complications with peritonitis.(Preoperatively, 6 hours postoperatively and on first, third and fifth postoperative day)

研究者

发起方
Copenhagen University Hospital, Hvidovre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mirjana Cihoric

MD, Research fellow

Copenhagen University Hospital, Hvidovre

研究点 (1)

Loading locations...

相似试验

Pathophysiology of Perioperative Fluid Management in... | 临床试验