跳至主要内容
临床试验/NCT04893382
NCT04893382终止不适用

Deciphering the Inflammatory Consequences of Crystalloids Used in the Resuscitation of Severely Burned Patients

Centre hospitalier de l'Université de Montréal (CHUM)2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年10月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
14
试验地点
2
主要终点
Change in monocyte phenotype from admission to day 10

研究概览

简要总结

This is a pilot study, but the investigators will also observe key immunological events with potential significance. The global objective is to study the inflammatory profiles of PlasmaLyte and Ringer's Lactate used in the initial massive fluid resuscitation of severely burned patients. On the long term, the investigators will identify the crystalloid that prevents hyperactivation of macrophages and death of severely burned patients.

详细描述

The investigators have 4 specific objectives. First, the investigators will compare the activation profiles of macrophages and neutrophils in patients admitted to the severely burned unit with regards to the crystalloids used. Secondly, the investigators will assess the differences in the SOFA scores according to the crystalloids used. Thirdly, the investigators will evaluate the impact of crystalloids in the quality of skin grafts performed on severely burned patients. Lastly, with the help of a patient partner, the investigators will determine the right immunological terminology of the study for a non-scientific population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • admission to the CHUM
  • more than 20% of burned area
  • first blood withdrawal in the first 24 hours following burn

排除标准

  • immunosuppression
  • chemotherapy 6 months before admission
  • radiotherapy 6 months before admission
  • autoimmune diseases
  • neoplasia
  • pregnancy
  • severe infections
  • cardiac dysfunctions
  • renal dysfunction
  • hepatic dysfunctions
  • Hepatitis C

结局指标

主要结局

Change in monocyte phenotype from admission to day 10

时间窗: Pre-infusion to day 10 post-infusion

Following blood draws, monocytes will be subjected to flow cytometry for phenotype evaluation.

次要结局

未报告次要终点

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验