| CTRI Number |
CTRI/2024/06/068373 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Characteristics and Outcomes of Patients hospitalised with dengue |
|
Scientific Title of Study
|
Epidemiology and outcomes of patients hospitalized with Dengue: Protocol for a prospective public health surveillance study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharath Kumar TV |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Main Hospital |
| Address |
Department of Critical Care Medicine, 2nd Floor, Apollo Main Hospital, Greams Lane, Chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
9591100655 |
| Fax |
|
| Email |
bharath@icuconsultants.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bharath Kumar TV |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Main Hospital |
| Address |
Department of Critical Care Medicine, 2nd Floor, Apollo Main Hospital, Chennai
TAMIL NADU
600006
India |
| Phone |
9591100655 |
| Fax |
|
| Email |
bharath@icuconsultants.com |
|
Details of Contact Person
Public Query
|
| Name |
Bharath Kumar TV |
| Designation |
Senior Consultant |
| Affiliation |
Apollo Main Hospital |
| Address |
Department of Critical Care Medicine, 2nd Floor, Apollo Main Hospital, Greams Lane, Chennai
TAMIL NADU
600006
India |
| Phone |
9591100655 |
| Fax |
|
| Email |
bharath@icuconsultants.com |
|
|
Source of Monetary or Material Support
|
| European Society of Intensive Care Medicine, Rue Belliard, 19
B-1040 Brussels
Belgium |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals Educational and Research Foundation |
| Address |
Krishnadeep Chambers, Wallace Garden, Chennai, 600006 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ajay Padmanaban |
Apollo Main Hospital |
Department of Critical Care Medicine, MDCCU, 2nd floor, 21,Greams Lane, Chennai
Chennai
TAMIL NADU |
9840264784
ajay@icuconsultants.com |
| Urvi Shukla |
Symbiosis Hospital |
Department of Critical Care Medicine, Building 3, 3rd floor, Lavala, Taluka Mushi
Pune
MAHARASHTRA |
9922994977
urvi.shukla@suhrc.siu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Research Committee, Symbiosis Hospital |
Approved |
| Institutional Ethics Committee |
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 |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with suspected or confirmed dengue (based on laboratory confirmation or per WHO or respective Ministry of Health diagnostic criteria). and admitted to a participating hospital. |
|
| ExclusionCriteria |
| Details |
lack of informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Survival of intensive care unit stay |
ICU discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| hospital survival, need for organ support |
at the time of ICU & hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/06/2024 |
| 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="1"
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
|
Research questions: - For patients hospitalized with Dengue, what are the patterns of clinical presentation, illness severity, treatments received, and outcomes?
- What are the patient and treatment-related predictors of hospital mortality for the cohort of severe dengue patients admitted to ICUs?
Objectives: - To describe the clinical presentation, demographics, including socio-economic determinants, illness severity, biochemical and hematological abnormalities, treatments received (fluids, vasopressors, organ support strategies, antiviral and anti-inflammatory medications) and outcomes for all dengue patients admitted to participating hospitals and ICUs over a 6-month period.
- To evaluate treatment-related predictors of mortality for the cohort of severe dengue patients admitted to ICUs using modern causal inference approaches.
Methods and Measurements: Study design: Prospective public health surveillance protocol Inclusion criteria: Patients diagnosed with suspected or confirmed dengue (based on laboratory confirmation or per WHO or respective Ministry of Health diagnostic criteria). and admitted to a participating hospital. Exclusion criteria: The only exclusion criteria would be lack of informed consent in jurisdictions that mandate the need for consent. Outcome measures: Our aim is to describe the clinical presentation (duration of illness, symptoms), demographics including socio-economic determinants, co-morbidities, illness severity (clinical, biochemical, laboratory, need for organ support), treatments received (IV fluids [type, volume, duration], blood and blood product transfusions, organ support provided during hospital stay, experimental therapies [corticosteroids, plasma exchange, IV immunoglobulins etc.], and outcomes [survival, ICU and hospital length of stay). Where feasible, we will also collect information on viral serotype/genotype. We will also evaluate treatment-related predictors of survival for the cohort of severe dengue patients using modern causal inference methods such as target trial emulation with a specific focus on steroids, plasma exchange and IVIg.
|