| CTRI Number |
CTRI/2024/10/074768 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Blood parameters used to predict severe cases of dengue at a tertiary centre |
|
Scientific Title of Study
|
PREDICTION OF SEVERITY OF DENGUE USING HEMATOLOGICAL PARAMETERS AT A TERTIARY CARE CENTRE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Rajan |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College and Hospital, Hyderabad |
| Address |
Department of General Medicine, 4th floor, ESIC Medical College and Hospital, Sanath Nagar, Hyderabad, Telangana.
Hyderabad
TELANGANA
500038
India |
| Phone |
8374443450 |
| Fax |
|
| Email |
aishwaryarajan29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aishwarya Rajan |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College and Hospital, Hyderabad |
| Address |
Department of General Medicine, 4th floor, ESIC Medical College and Hospital, Sanath Nagar, Hyderabad, Telangana.
Hyderabad
TELANGANA
500038
India |
| Phone |
8374443450 |
| Fax |
|
| Email |
aishwaryarajan29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Rajan |
| Designation |
Assistant Professor |
| Affiliation |
ESIC Medical College and Hospital, Hyderabad |
| Address |
Department of General Medicine, 4th floor, ESIC Medical College and Hospital, Sanath Nagar, Hyderabad, Telangana.
Hyderabad
TELANGANA
500038
India |
| Phone |
8374443450 |
| Fax |
|
| Email |
aishwaryarajan29@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESIC Medical College and Hospital, Sanath Nagar, Hyderabad, Telangana, India. 500038 |
|
|
Primary Sponsor
|
| Name |
Aishwarya Rajan |
| Address |
ESIC Medical College and Hospital, sanath Nagar, Hyderabad, Telangana, India. 500038 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Rajiv Kumar Bandaru |
ESIC Medical College and Hospital |
ESIC Medical College and Hospital, Sanath Nagar, Hyderabad, Telangana
Hyderabad
TELANGANA |
9885633040
Rajiv.b@esic.nic.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ESIC Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B338||Other specified viral diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of age who give consent and patients with NS1 and/or IgM Dengue positive |
|
| ExclusionCriteria |
| Details |
Patients who do not give consent and have IgG Dengue positive. Patients who have co-infection with other bacterial or viral etiology |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Monitor patients since the day of diagnosis to discharge/death and correlate the monocytosis to severity of dengue |
Day of diagnosis to day of discharge/death |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for correlation between monocytosis and thrombocytopenia |
Day of diagnosis to day of discharge/death |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/10/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Dengue is the most rapidly spreading mosquito-borne viral disease in the world. In the last 50 years, incidence has increased 30-fold with increasing geographic expansion to new countries and, in the present decade, from urban to rural settings. Although DENV infects several cell types, monocytes, macrophages and mast cells are major responders to DENV infection. DENV infection of monocytes triggers the release of numerous immunological factors, some of which modulate the function of other cells, particularly vascular endothelial cells. monocyte-secreted factors can prime or trigger endothelial cell permeability leading to vascular leakage, a major hallmark of severe dengue disease. Monocytosis is a hematological parameter that will help us identify patients that may have severe dengue- dengue shock syndrome/dengue hemorrhagic fever. This further helps us to be prepared for the treatment of severe dengue and hence help is reducing mortality. |