| CTRI Number |
CTRI/2021/05/033327 [Registered on: 03/05/2021] Trial Registered Prospectively |
| Last Modified On: |
12/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to predict which parameters of patients with COVID19 admitted in ICU determine the prognosis |
|
Scientific Title of Study
|
Developing a scoring system to predict the outcome of patients with COVID19 admitted in COVID ICU |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rangapriya a |
| Designation |
post graduate |
| Affiliation |
Srm Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology 2nd floor, room No 209
SRM Medical College Hospital
Potheri
Kancheepuram
TAMIL NADU
603203
India
Department of Anaesthesiology 2nd floor, room No 209
SRM Medical College Hospital
Potheri
Kancheepuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9449058234 |
| Fax |
|
| Email |
rangapriya.a@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gayathri |
| Designation |
Professor Head |
| Affiliation |
srm Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology 2nd floor, room No 209
Srm Medical College Hospital
Potheri
Kancheepuram
TAMIL NADU
603203
India
Department of Anaesthesiology 2nd floor, room No 209
Srm Medical College Hospital
Potheri
Kancheepuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri |
| Designation |
Professor Head |
| Affiliation |
srm Medical College Hospital and Research Centre |
| Address |
Department of Anaesthesiology 2nd floor, room No 209
Srm Medical College Hospital
Potheri
chengalpattu
TAMIL NADU
603203
India
Department of Anaesthesiology 2nd floor, room No 209
Srm Medical College Hospital
Potheri
chengalpattu
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500092905 |
| Fax |
|
| Email |
gayathrii.r@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Institute of Science and Technology, Srm nagar, Potheri, kancheepuram District,
Tamilnadu - 603203
|
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital |
| Address |
Room no 1, B Block, Department of Anaesthesiology Potheri
Kattankulathur 603203 Kancheepuram TAMIL NADU |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rangapriya A |
SRM Medical College Hospital |
Room no 1, B Block,
Department of
Anaesthesiology
Srm Medical College Hospital Potheri
Kattankulathur
Kancheepuram
TAMIL NADU
603203
Kancheepuram
TAMIL NADU |
09449058234
rangapriya.a@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
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 |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with covid pneumonia with spo2<94% on oxygen support admitted in ICU.
|
|
| ExclusionCriteria |
| Details |
Age below 18years
pregnant and breast feeding females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to predict the parameters which determine the outcome of seriously ill covid patients in terms of mortality |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
NO of Days of ICU admission
|
1 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
27/05/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, we aimed to identify the risk factors for mortality of covid infected patients admitted in icu. we aim at determining a scoring system to predict the mortality by considering the various parameters required for monitoring and decision making in treating patients affected with covid pneumonia. this can be utilized by clinicians/intensivist for risk stratification and effective treatment.
|