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临床试验/NCT01768936
NCT01768936已完成不适用

Procalcitonin Ratio's Impact on the Decision Upon On-demand Relaparotomy in Septic Peritonitis

CHIR-Net1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2009年1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
234
试验地点
1
主要终点
prediction of focus elimination: cured patients versus patients with persisting peritonitis (definitions see below)

研究概览

简要总结

Procalcitonin (PCT) serum levels are monitored in patients with secondary peritonitis after initial operative focus elimination to investigate the PCT ratio's impact on decision-making for or against early relaparotomy in the on-demand relaparotomy concept of secondary septic peritonitis.

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

  • age >18 years
  • necessity for operative intervention to eliminate an infectious peritoneal / abdominal focus after organ perforation
  • abdominal sepsis according to the American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference definition

排除标准

  • pregnancy
  • immunosuppressive medication

结局指标

主要结局

prediction of focus elimination: cured patients versus patients with persisting peritonitis (definitions see below)

时间窗: participants will be followed for the duration of hospital stay, an expected average of 21 days

definition of 'focus elimination': patients with intestinal perforation or anastomotic leakage develop (local) peritonitis and consecutive abdominal sepsis. These patients need surgical intervention for focus elimination. This operative intervention aims to eradicate all infectious material and is intended to remove the leaking intestinal lesion. Whether this focus is eliminated or not can be controlled by either planned relaparotomy (normally within 48h after the first operation) or on demand relaparotomy in case of clinical deterioration. The focus can be assumed to be eliminated in all cases where either relaparotomy reveals no ongoing infection or persisting focus and whenever a patient recovers rapidly after initial surgery.

次要结局

未报告次要终点

研究者

发起方
CHIR-Net
申办方类型
Network
责任方
Sponsor

研究点 (1)

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