| 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
|
|
|
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
|
|
|
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. |