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临床试验/CTRI/2024/05/067373
CTRI/2024/05/067373尚未招募4 期

Comparison of Acute Physiology and Chronic Health Evaluation IV score and serum hepcidin levels as predictor of mortality in patients admitted to intensive care unit

Government Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年6月28日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Comparison of Acute Physiology and Chronic Health Evaluation IV score and serum hepcidin levels as predictor of mortality in patients admitted to intensive care unit

研究概览

简要总结

Despite advanced health setups, ICU related mortality and morbidity still remains high, this is due to lack of early diagnosis and intervention. APACHE IV score is the  standard indicator for mortality. For more specific we have to find some more indicators to assess the mortality. Serum hepcidin is an acute phase reactant. In critically ill patients, hepcidin level will be increased due to its acute inflammatory action, with the help of serum hepcidin level, we can diagnose the condition specifically and treatment will be given early.

Initially APACHE IV score is calculated in patients admitted in ICU, after 48 hours of admission blood sample will be taken to evaluate serum hepcidin level. In the mean time after 48 hours of admission SOFA score is going to be calculated.it is done in every alternative days at a given designated time. SOFA score is evaluated to assess the sepsis, change in SOFA score is more than 2 from the baseline or previous one will indicate the development of sepsis.

 

Serum hepcidin level measured under ELISA method, APACHE IV score is calculated and these measurements will be charted. We observe the outcome of the patient and correlate with measurements of serum hepcidin level and APACHE IV score. With the help of this parameter especially serum hepcidin level, we are going to assess the patient’s mortality prediction, In the way we can take appropriate steps to diagnose and manage the patient early and decrease the mortality with help of APACHE IV score and serum hepcidin level.

It was decided to enroll 80 patients in the present trial to compensate for the dropouts. Therefore, after written informed consent, 80 patients of either gender will be enrolled for the present trial according to the inclusion and exclusion criteria

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • Age more than 18 years, Below 65 years, Patient in ICU stay more than 48 hours.

排除标准

  • Refusal to consent from patient’s relative
  • ICU stay less than 2 days (shift to ward or discharge within 2 days)
  • Head injury
  • Patients receiving chemotherapy/ having malignancy.

结局指标

主要结局

Comparison of Acute Physiology and Chronic Health Evaluation IV score and serum hepcidin levels as predictor of mortality in patients admitted to intensive care unit

时间窗: APACHE IV score will be calculated within 24 hours of admission in ICU. | Serum hepcidin level measured after 48 hours of admission in ICU.

次要结局

  • Correlation of APACHE IV score with development of sepsis and length of stay in ICU(APACHE IV score will be calculated within 24 hours of admission in ICU.)
  • Correlation of serum hepcidin levels with development of sepsis and length of stay in ICU(Serum hepcidin level will be measured after 48 hours of admission in ICU.)
  • Correlation of SOFA score to predict the development of sepsis(SOFA score calculated after 48 hours of admission and will be done every alternate days at a given designated time)

研究者

发起方
Government Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Balamurugan M

Government Medical College and Hospital, Sector 32B, Chandigarh

研究点 (1)

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