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CTRI Number  CTRI/2024/07/071075 [Registered on: 23/07/2024] Trial Registered Prospectively
Last Modified On: 22/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Determining the role of Liver enzymes and Platelet counts in predicting the severity of Dengue fever 
Scientific Title of Study   Assessing the role of Aspartate transaminase to Platelet count ratio index (APRI) in predicting severe Dengue 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nallani Ch Saketh Ram 
Designation  Junior Resident 
Affiliation  Kasturba Medical College Manipal 
Address  Department of General Medicine Kasturba Medical College Madhav Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  9121586273  
Fax    
Email  sakethnallan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Raghavendra Rao 
Designation  Associate Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of General Medicine Kasturba Medical College Madhav Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  9901731924  
Fax    
Email  ragsmanipal1983@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Raghavendra Rao 
Designation  Associate Professor 
Affiliation  Kasturba Medical College Manipal 
Address  Department of General Medicine Kasturba Medical College Madhav Nagar Manipal

Udupi
KARNATAKA
576104
India 
Phone  9901731924  
Fax    
Email  ragsmanipal1983@gmail.com  
 
Source of Monetary or Material Support  
Department of General Medicine Kasturba Medical College Madhav Nagar Manipal Udupi District Karnataka State PIN-576104 
 
Primary Sponsor  
Name  Department of General Medicine Kasturba Medical College 
Address  Kasturba Medical College Madhav Nagar Manipal Udupi District Karnataka State PIN- 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nallani Ch Saketh Ram  Kasturba Hospital Manipal  Department of General Medicine Kasturba Medical College Madhav Nagar Manipal Udupi District Karnataka State PIN - 576104
Udupi
KARNATAKA 
9121586273

sakethnallan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KASTURBA MEDICAL COLLEGE AND KASTURBA HOSPITAL INSTITUTIONAL ETHICS COMMITTEE - STUDENT RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A90-A99||Arthropod-borne viral fevers and viral hemorrhagic fevers,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients more than 18 years of age diagnosed with dengue by either NS1 antigen assay or by Anti-Dengue IgM assay 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
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
 
Cross Sectional Study 
 
Secondary Outcome  
Outcome  TimePoints 
APRI values in dengue survivors and dengue related deaths
APRI values in different types of complications of dengue will be compared
Degree of association between severity and APRI would be estimated. 
Cross Sectional Study 
 
Target Sample Size   Total Sample Size="158"
Sample Size from India="158" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

·       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.


 
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