跳至主要内容
临床试验/CTRI/2024/09/073246
CTRI/2024/09/073246招募中不适用

Study of inflammatory markers in critically ill trauma elderly patients and its correlation with trauma severity score: a prospective observational study

Banaras Hindu University1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2024年9月2日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
116
试验地点
1
主要终点
1.To correlate inflammatory markers with trauma severity score.

研究概览

简要总结

This study will be carried out in patients who will be admitted to ICU, Trauma Centre, Institute of Medical Sciences, Banaras Hindu University. Patient data will be collected from the patient/ relative and from the admission record. Data is collected in the form of age and sex of the patient, date and time of injury, date and time of admission to ICU, severity of injury in the form of trauma scorings - 1. Revised Trauma Score (RTS), 2. Injury Severity Score (ISS), .3 Trauma and Injury Severity Score (TRISS), 4. Probability of Survival (Ps17) and 5. Geriatric Trauma Outcome Score (GTOS).

Within 24 hours of trauma, the blood samples for IL-6, TNF-alpha, PCT and at 72 hours for CRP will be sent to lab where the samples undergo cooling centrifugation, plasma will be aliquoted, frozen and stored. Levels of biomarkers will be assessed after final sample collected using ELISA method. In the meantime, patient will be followed up every 24 hours for 30 days for assessing 30-day mortality. In addition, the patients assessed every 24 hours for length of hospital stay and use of mechanical ventilation/ vasopressors till the discharge / death of the patient whichever is earlier.

The obtained data will be recorded and the results will be statistically analysed by appropriate statistical methods. A p value of 0.05 will be considered as significant.

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
60.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Geriatric patients of age between 60 and 99 years 2.Geriatric trauma patients requiring ICU admissions.

排除标准

  • 1.Non traumatic causes requiring ICU admissions 2.Patients dying within first 24 hours of trauma /died in the Emergency Department 3.Patients with known pre-existing immunological disorders and malignancies 4.Patients on immunosuppressants and anticoagulants 5.patients discharged against medical advice 6.patients/attendants of patients who are not willing to participate in the study.

结局指标

主要结局

1.To correlate inflammatory markers with trauma severity score.

时间窗: 1.Initial baseline inflammatory markers and trauma severity scores will be taken to correlate 30 day mortality.

次要结局

  • 1.Length of hospital stay
  • 2.Requirement of mechanical ventilation/vasopressors(Patient will be assessed every 24 hours after admission till discharge/death of patient whichever is earlier)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Logesh R

Institute of Medical Sciences, Banaras Hindu University

研究点 (1)

Loading locations...

相似试验