跳至主要内容
临床试验/NCT02189434
NCT02189434已完成不适用

A Pilot Study to Determine the Correlation of Serum Procalcitonin Levels and Development of Sepsis in Patients Undergoing Cytoreductive Surgery

Eastern Regional Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
The primary objective of this study is to determine the natural progression of serum procalcitonin in patients recovering from cytoreductive surgery, with or without HIPEC.

研究概览

简要总结

Serum procalcitonin levels will be considerably higher, for a longer period of time, in patients who develop sepsis compared to patients with SIRS or those who have an uncomplicated post-surgical recovery. Monitoring of serum procalcitonin trends will allow for an earlier diagnosis of, and initiation of treatment for, sepsis compared to current standard ICU methods.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Female or male person ≥ 18 years of age
  • Biopsy proven carcinoma
  • Scheduled for cytoreductive surgery, with or without HIPEC
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0, 1, or 2
  • Able to give informed consent for protocol participation

排除标准

  • Participants are not able to understand or provide written informed consent
  • Pre-operative anti-inflammatory medication use within 72 hours of their baseline blood draw
  • Pre-operative infection treatment with corticosteroids within 72 hours of their baseline blood draw
  • Immunosuppressive illness other than neoplasm
  • Pregnant or lactating female

结局指标

主要结局

The primary objective of this study is to determine the natural progression of serum procalcitonin in patients recovering from cytoreductive surgery, with or without HIPEC.

时间窗: end of study

次要结局

  • Observe the patient's post-operative course with regards to serum procalcitonin levels and development of sepsis in patients previously treated with cytoreductive surgery with or without HIPEC.(end of study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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