跳至主要内容
临床试验/CTRI/2024/07/071075
CTRI/2024/07/071075尚未招募不适用

Assessing the role of Aspartate transaminase to Platelet count ratio index (APRI) in predicting severe Dengue

Department of General Medicine Kasturba Medical College1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2024年8月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
158
试验地点
1
主要终点
At the end of the study APRI values in different groups of dengue illness will be studied and compared. APRI values of severe dengue, dengue with warning signs and dengue without warning signs

研究概览

简要总结

·       After taking prior permission from the Head of Department of Medicine, the subjects will be recruited in the study.

·       A participant information sheet containing the particulars of the study would be given and the subjects would be explained about the objectives of the study. Informed consent will be taken from the subjects. Both (Participant Information Sheet and Informed Consent) will be made available in English and also in the local language Kannada.

·       The details of the report will be kept confidential.

·       All the patients who are above 18 years of age and positive for dengue illness which is confirmed by doing a dengue IgM antibody using a kit of National Institute of Virology, Pune or by NS1 antigen testing done using Pan bio ELISA kit and who consent for the study will be recruited to the study.

·       Demographic details including age, sex , symptoms, bleeding manifestation, comorbidities, general and systemic examination findings, laboratory investigations such as complete blood profile, renal function tests, liver function tests, c-reactive protein, electrocardiogram, chest x-ray, ultrasound abdomen and coagulation parameters will be recorded in a predesigned proforma.

·       Platelet count would be estimated using automated hematology analyser

·       APRI will be calculated using the formula mentioned

·       Patients will be classified based on the severity of dengue according to the 2009 revised WHO criteria(Figure.1) as non-severe dengue and severe dengue. The non-severe dengue group will be further categorised as dengue with warning signs and without warning signs

·       Estimation of AST and platelet count and calculation of APRI will be done for all the patients who would be recruited and comparison will be done in each of this group based on the severity.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Patients more than 18 years of age diagnosed with dengue by either NS1 antigen assay or by Anti-Dengue IgM assay.

排除标准

  • Patients with preexisting liver disease Patients testing positive for HIV HBV HCV on routine serological testing Patients with other causes of thrombocytopenia including ITP Patients with abnormalities in hematological cell lines Patients with secondary bacterial infections Patients not willing to provide consent.

结局指标

主要结局

At the end of the study APRI values in different groups of dengue illness will be studied and compared. APRI values of severe dengue, dengue with warning signs and dengue without warning signs

时间窗: Cross Sectional Study

次要结局

  • APRI values in dengue survivors and dengue related deaths(APRI values in different types of complications of dengue will be compared)

研究者

发起方
Department of General Medicine Kasturba Medical College
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Nallani Ch Saketh Ram

Kasturba Medical College Manipal

研究点 (1)

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