| CTRI Number |
CTRI/2024/09/073676 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To compare efficacy of clinical scores in critically ill elderly patients using severity of illness, comorbidities and frailty. |
|
Scientific Title of Study
|
Outcome prediction in critically ill elderly patients using severity of illness, comorbidities and frailty scores and their comparison: A prospective observational 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 |
Dr Vinay Kumar Maurya |
| Designation |
DrNB Critical Care Medicine |
| Affiliation |
Max Super Speciality Hospital, Saket, New Delhi |
| Address |
1,2, Press Enclave Road, Saket, New Delhi
West Block, 6th floor MICU
South
DELHI
110017
India |
| Phone |
09729778386 |
| Fax |
|
| Email |
vkm708@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deven Juneja |
| Designation |
Director |
| Affiliation |
Max Super Speciality Hospital, Saket, New Delhi |
| Address |
1,2, Press Enclave Road, Saket, New Delhi
West Block, 6th floor MICU
South
DELHI
110017
India |
| Phone |
09818290380 |
| Fax |
|
| Email |
deven_juneja@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deven Juneja |
| Designation |
Director |
| Affiliation |
Max Super Speciality Hospital, Saket, New Delhi |
| Address |
1,2, Press Enclave Road, Saket, New Delhi
West Block, 6th floor MICU
South
DELHI
110017
India |
| Phone |
09818290380 |
| Fax |
|
| Email |
deven_juneja@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital, Saket, New Delhi |
|
|
Primary Sponsor
|
| Name |
Vinay Kumar Maurya |
| Address |
Department Of Critical Care Medicine, Max Super Speciality Hospital, Press Enclave Road, Saket, New Delhi - 110017 |
| Type of Sponsor |
Other [self] |
|
|
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 Vinay Kumar Maurya |
Max Super Speciality Hospital, Saket, New Delhi. |
MICU, 6th Floor, West Block, Department of Critical Care Medicine, Max Super Speciality Hospital, Press Enclave Road, Saket, New Delhi - 110017.
South
DELHI |
09729778386
vkm708@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R99||Ill-defined and unknown cause of mortality, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
OBSERVATIONAL STUDY |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 60 years
All study subjects who are willing to give informed consent for participation in the study |
|
| ExclusionCriteria |
| Details |
History of cardiopulmonary resuscitation
ICU stay less than 24hours
Those with donot resuscitate and donot intubate orders
Subsequent ICUs admissions during the same hospitalization |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of different clinical scores to predict ICU mortality in critically ill elderly patients in medical ICUs critically ill elderly patients in medical ICUs |
Will be observed till patients in hospital. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out the overall ICU mortality and length of stay in elderly patients in medical ICUs.
Factors associated with increased mortality. |
12-18months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/09/2024 |
| 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="5"
Days="30" |
|
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
|
Elderly OR senior citizens have been defined in the National policy for older persons as people with age more than 60 years. In India’ forecasts predict the percentage of population older than 60 years will increase from 8% in 2015 to 19% in 2050. In the past decade, there is an increase in admissions of elderly individuals into intensive care units (ICU).
As per literature, elderly patients makeup betweeen 26% and 51% of Icu admissions. Studies have reported the mortality rates in elderly ICU patients varying from 3% to 64%, depending upon the type of patients studied.
The commonly associated factors with increased mortality among elderly patients can be broadly classified into severity of illness, comorbidities and fraility. These factors in icu can be measured using tools such as APACHE II, SOFA score for severity of illness, Charlson and Elixhause comorbidity indices for comorbidities, Clinical Fraility Scale and mFI-11 for fraility in older people. However, these parameters have not been compared in a single study. Hence, we aimed to compare the various scores and evaluate their efficacy in predicting outcomes of critically ill elderly patients admitted in MICUs |