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临床试验/CTRI/2024/05/066596
CTRI/2024/05/066596尚未招募不适用

Fever with special emphasis on Central fever in a traumatic brain injury patients admitted in Trauma ICU: A Prospective Cohort study

未提供1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年5月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
试验地点
1
主要终点
Analysis of the incidence of various causes of fever in Trauma ICU in traumatic brain injury patients.

研究概览

简要总结

This study will be conducted in department of Anaesthesiology,IMS,BHU,Varanasi after obtaining written and informed consent and institutional ethical approval.After CTRI registration, patients fulfilling inclusion criteria will be included in this study and will be further evaluated by sending laboratory investigations and analyzing the clinical parameters. Demographic data and empirical antibiotics in use on patient will also be recorded. Various laboratory investigations include Complete blood count , C- reactive protein, chest X-ray , pro calcitonin levels and culture . Patients having positive culture reports will be classified as infectious fever and antibiotic escalation/deescalation will be done based on sensitivity report. Patients with negative culture report will be further evaluated to identify various other causes of fever and will be classified separately to calculate the incidence of various causes of fever . Patients included under neurogenic fever will be further evaluated and all the relevant clinical data from the onset of fever will be collected .This will include medical history , presenting symptoms and result of diagnostics tests.

Based on objective of study , descriptive and inferential statistics will be drawn to determine the association of provided variables with neurogenic fever and a comprehensive list of variables will be formulated . This list will consists of variables that demonstrate high diagnostic accuracy for Central fever .

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients having fever episodes with history of traumatic brain injury Traumatic brain injury patients requiring mechanical ventilation.
  • Body temperature more than 38 degree Celsius (100.94 degree Fahrenheit) at least for 2 consecutive days OR single episode of more than 39.5 degree Celsius (103.1 degree Fahrenheit).

排除标准

  • Refusal to give consent .
  • History of Malignant Hyperthermia , heat stroke , neuroleptic malignant syndrome and serotonin syndrome .
  • Patient getting referred from other ICU facility .
  • Patient with possible endocrine issues ( like pheochromocytoma , adrenal crisis , thyrotoxicosis ) .
  • Immunocompromised / on chemotherapy/ neutropenic patients.

结局指标

主要结局

Analysis of the incidence of various causes of fever in Trauma ICU in traumatic brain injury patients.

时间窗: Within 28 days

次要结局

  • To analyze the association of various laboratory and clinical variables with the central fever in the patients of traumatic brain injury in Trauma ICU.(Day1 ,Day3 and Day5)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Sonal Goswami

Institute of Medical sciences, Banaras Hindu University

研究点 (1)

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