跳至主要内容
临床试验/NCT04894500
NCT04894500已完成不适用

The Intensive Care Infection Score in Adult and Paediatric Burns in Comparison to Other Inflammatory Markers

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 97 人开始时间: 2021年4月1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
97
试验地点
1
主要终点
The Intensive Care Infection Score is not inferior to selected inflammatory markers in detection of bacterial infection

研究概览

简要总结

The current markers of inflammation that govern antibiotic treatment have their significant limitations, especially in patients with burns. According to previously published data, the newly proposed marker of infectious inflammation, the Intensive Care Infection Score (ICIS), appears to be a suitable diagnostic tool in distinguishing between inflammation of infectious and non-infectious origin in these patients. The other advantage is its low price.

This study aims to compare ICIS with other used indicators of inflammation in patients with burns both children and adults.

详细描述

Improving the use of antibiotics is an important patient and public health issue. The misuse of antibiotics has contributed to the growing problem of antibiotic resistance, which has become one of the most serious and growing threats to public health.

The prompt initiation of antibiotics to treat infections has been proven to reduce morbidity and save lives, however, up to 30% of all antibiotics prescribed in ITUs are either unnecessary or inappropriate. One of the key problems is early and reliable detection of infection. Specificity of clinical signs and routine laboratory markers is low and they usually cannot distinguish among changes caused by the primary insult, inflammatory reaction, and infection.

The gold standard of systemic bacterial and fungal infection, i.e. positive blood culture, has a sensitivity of less than 75 per cent and its contamination has been found in up to one third of results. Sputum and urine cultures are contaminated even more. Moreover, culture results are usually not known earlier than after 48 hours and antibiotic treatment should be started earlier in many cases, especially in the case of septic shock.

New diagnostic modalities have been developed to sort out difficulties with early and reliable diagnosis of a presence of infection, for example measurement of Procalcitonin (PCT) or Presepsin level, matrix-assisted laser desorption ionization time-of-flight detector mass spectrometry (MALDI TOF MS), DNA hybridisation, and polymerase chain reaction (PCR) tests, eventually polymerase chain reaction electrospray ionization mass spectrometry (PCR ESI-MS).

PCT examination is the most used laboratory test from the modalities mentioned above. Despite many positive characteristics (i.e. fast dynamics of plasma changes, higher sensitivity and specificity than C-reactive protein, ability to distinguish between G+ and G- infection), PCT specificity drops in patients with ARDS, burns, multiple injuries, rhabdomyolysis, lysis of lymphocytes, extreme metabolic situations, organ perfusion failure and after large surgical procedures. It is also worth mentioning the relatively high cost of this examination, limiting the use of this marker for routine screening, especially in low- and middle-income countries.

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
6 Months 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients hospitalized on Prague Burn Centre, Czech Republic, for more than 3 days.

排除标准

  • Refusal to sign informed consent or withdrawal of already signed consent;
  • Patient in palliative care.

结局指标

主要结局

The Intensive Care Infection Score is not inferior to selected inflammatory markers in detection of bacterial infection

时间窗: 15 days

Comparison of the ICIS to CRP, PCT, IL-6, WBC, TNF-α, and Presepsin

次要结局

  • The Intensive Care Infection Score does not depend on the extend and depth of the burn area(5 days)
  • The Intensive Care Infection Score is a suitable biomarker for distinguishing bacterial infection from systemic inflammatory response syndrome (SIRS)(30 days)
  • The Intensive Care Infection Score is a suitable marker of bacterial infection in children with burns(10 days)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bohumil Bakalar MD

Intensive Care lead

Charles University, Czech Republic

研究点 (1)

Loading locations...

相似试验