| 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
|
|
|
Primary Sponsor
|
| Name |
jss medical college |
| Address |
jss medical college
mysore |
| 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 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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
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 |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
|
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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
|
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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 storm2. Clinical 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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