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CTRI Number  CTRI/2024/01/062067 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On: 05/01/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   prevalence of heart related issues in patients admitted to intensive care unit having fever of less than 15 days of duration and having low blood pressure 
Scientific Title of Study   Prevalence of cardiac dysfunction in patients with acute febrile illness with shock admitted in intensive care unit 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Margiben Tusharbhai Bhatt 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Critical Care Medicine, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, End point road, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922033  
Fax    
Email  drmargibhatt@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Margiben Tusharbhai Bhatt 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Critical Care Medicine, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, End point road, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922033  
Fax    
Email  drmargibhatt@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Margiben Tusharbhai Bhatt 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College, MAHE, Manipal 
Address  Department of Critical Care Medicine, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, End point road, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922033  
Fax    
Email  drmargibhatt@hotmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal 
Address  Department of critical care, Kasturba Medical College, Manipal, Manipal Academy of higher Education, Manipal-576104, Karnataka, India. 
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 Margiben Tusharbhai Bhatt  Kasturba Medical college and hospital  Department of Critical Care Medicine, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, End point road, Manipal
Udupi
KARNATAKA 		 08202922033

drmargibhatt2809@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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I408||Other acute myocarditis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  patients aged 18-80 years having acute febrile illness with shock admitted to ICU 
 
ExclusionCriteria 
Details  1. Patients with a single localized source of infection
2. Patients with known ischemic heart disease, or autonomic dysfunction
3. Any patient who is terminally ill due to any cause and is not expected to survive the next 48 hours 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the prevalence of cardiac dysfunction in patients with acute febrile illness in the intensive care unit (ICU)  over the period of two years 
 
Secondary Outcome  
Outcome  TimePoints 
to assess the mortality predictors in patients admitted with severe acute febrile illness in the ICU  over the period of two years 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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)   01/02/2024 
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 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  

Patients with AFI (acute febrile illness) often present with sepsis, and progression to multi-organ dysfunction ensues.[1] In tropical climate AFI is one of the most usual presentation we encounter during and after the monsoon season.[2] AFI is defined as fever ≥ 38 °C and < 15 days duration without a localized source of infection.[3] Dengue fever, scrub typhus and leptospirosis are common AFIs in our region, and if severe, these are associated with significant morbidity and mortality leading to multi-organ dysfunction syndrome (MODS).[4] The frequency and extent of cardiac involvement in leptospirosis and other tropical fevers, are under-reported and poorly understood. Leptospirosis associated myocardial dysfunction is equivocal and the pattern of cardiac involvement may not differ from that of sepsis associated myocarditis.[5] This study aims to look at the prevalence of cardiac dysfunction in patients admitted with acute febrile illness admitted to intensive care unit.


References:

1. Yilmaz H, Turhan V, Yasar KK, Hatipoglu M, Sunbul M, Leblebicioglu H. Characteristics of leptospirosis with systemic inflammatory response syndrome: a multicenter study. Ann Clin Microbiol Antimicrob. 2015 Dec 21;14:54. doi: 10.1186/s12941-015-0117-x. PMID: 26690093; PMCID: PMC4687284.

2.  Wangdi, K., Kasturiaratchi, K., Nery SV, Lau CL, Gray DJ, Clements ACA. Diversity of infectious aetiologies of acute undifferentiated febrile illnesses in south and Southeast Asia: a systematic review. BMC Infect Dis 19, 577 (2019). https://doi.org/10.1186/s12879-019-4185-y.

3. Bhaskaran, D., Chadha, S.S., Sarin, S. et al. Diagnostic tools used in the evaluation of acute febrile illness in South India: a scoping review. BMC Infect Dis 19, 970 (2019). https://doi.org/10.1186/s12879-019-4589-8.

4. Ray A, Mohta S, Soneja M, Jadon R, Wig N, Sood R. Clinical spectrum and outcome of critically ill hospitalized patients with acute febrile illness and new-onset organ dysfunction presenting during monsoon season. Drug Discov Ther. 2019;13(2):101-107. doi: 10.5582/ddt.2019.01023.

5. Caforio ALP, Pankuweit S, Arbustini E, et al. Current state of knowledge on aetiology, diagnosis, management, and therapy of myocarditis: A position statement of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases. Eur Heart J 2013; 34: 2636–2648, 2648a–2648d.

 
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