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CTRI Number  CTRI/2020/12/029586 [Registered on: 04/12/2020] Trial Registered Prospectively
Last Modified On: 03/12/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Various Blood Parameters Affecting outcome in ICU Patients  
Scientific Title of Study   Assessment of predictors of severity in COVID 19 patients admitted to intensive care unit of a tertiary care hospital  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Rajalakshmi R 
Designation  PROFESSOR AND HOD 
Affiliation  jss medicical college 
Address  DEPARTMENT OF PHYSIOLOGY JSSMC MYSORE
shivarathreshwaranagar bannimantap mysore
Mysore
KARNATAKA
570015
India 
Phone  8971415623  
Fax    
Email  rajalakshmir@jssuni.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  DR Rajalakshmi R 
Designation  Professor and HOD 
Affiliation  jss medicical college 
Address  DEPARTMENT OF PHYSIOLOGY JSSMC MYSORE
shivarathreshwaranagar bannimantap mysore
Mysore
KARNATAKA
570015
India 
Phone  8971415623  
Fax    
Email  rajalakshmir@jssuni.edu.in  
 
Details of Contact Person
Public Query
 
Name  DR Rajalakshmi R 
Designation  Professor And HOD 
Affiliation  jss medicical college 
Address  DEPARTMENT OF PHYSIOLOGY JSSMC MYSORE
shivarathreshwaranagar bannimantap mysore
Mysore
KARNATAKA
570015
India 
Phone  8971415623  
Fax    
Email  rajalakshmir@jssuni.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  jss medical college 
Address  jss medical college mysore 
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 AKSHAY  JSS MEDICAL COLLEGE AND HOSPITAL  Department of Anaesthesia And Critical care 3rd floor jss hospital MG road Mysore
Mysore
KARNATAKA 
9980891177

hmmakshay@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  Patients with COVID 19 infection admitted in ICU 
 
ExclusionCriteria 
Details  Patients not willing to give consent for the study 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the predictors of severity in COVID 19 patients admitted in Intensive care unit by analyzing the haematological and biochemical parameters.   on admission and every second day 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the association of vitamin D deficiency with the risk COVID–19 infection.  on admission  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/12/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  


Brief resume of intended work:

 A novel human coronavirus, first detected during an unexplained cluster of pneumonia cases in Wuhan, China in December 2019 has caused a global outbreak and has become a major public health problem worldwide. The World Health Organization (WHO) officially named this new coronavirus disease as COVID 19 and the virus causing it as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). WHO also declared COVID 19 as pandemic on March 21, 2020. According to WHO website as of August 28th, 2020, around 2,42,99,923 confirmed cases and 8,27,730  deaths have been reported from across the world  and  in India COVID 19  is around 3,94,513 confirmed cases and 62,669 deaths 1.  COVID 19 patient’s presents from mild symptoms of upper respiratory tract infection to severe respiratory failure. 80-85% of patients are asymptomatic or have self-limiting disease and remaining have severe disease.  Many COVID 19 individuals have died due to complications from some of the main risk factors for COVID 19 such as ARDS, pneumonia, coagulopathy, acute kidney failure, acute heart failure etc which is likely attributable to uncontrolled acute inflammation and cytokine storm2Clinical data obtained from COVID-19 patients in China reported high concentrations of cytokines in patients admitted to the ICU, which indicates the presence of cytokine storm in severe COVID-19 cases3. So it is important to know the levels of inflammatory markers to identify patients at high risk for severe COVID-19 and mortality.

          Human observational studies have frequently reported that higher vitamin D levels were associated with lower inflammatory markers including CRP, IL-6 and TNFα in healthy populations, and in those with proinflammatory conditions, such as diabetes, arteriosclerosis and inflammatory polyarthritis4. A cross-sectional analysis across Europe showed that COVID 19 mortality was significantly associated with vitamin D status in different populations and that vitamin D status was strongly associated with Covid-19 mortality 5.

        As the COVID 19 pandemic continues to increase and currently no effective vaccines or specific drugs against COVID 19 have been reported, the need to understand the predictors of severe COVID 19 is becoming important, so that early identification of severity and prognosis of COVID-19 enables early intervention for the reduction of mortality risk.  Hence we hypothesize that, haematological and biochemical markers in COVID 19 infection positive persons would be significantly associated with mortality and morbidity and vitamin D deficiency is associated with COVID 19.

 
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