| CTRI Number |
CTRI/2024/08/071902 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
RETROSPECTIVE |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
End of life care in ICU settings |
|
Scientific Title of Study
|
A Retrospective study of factors affecting decision making for ICU resource utilization and outcomes in patients admitted to the critical care units with triggers for palliative care referral on admission in tertiary care hospital in southern India |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ROSHAN JOSEPH FERNANDES |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KMC MANIPAL |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE
KMC MANIPAL
MADHAV NAGAR
MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
948150283 |
| Fax |
|
| Email |
roshan.fernandes@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
ROSHAN JOSEPH FERNANDES |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KMC MANIPAL |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE
KMC MANIPAL
MADHAV NAGAR
MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
948150283 |
| Fax |
|
| Email |
roshan.fernandes@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
ROSHAN JOSEPH FERNANDES |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
KMC MANIPAL |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE
KMC MANIPAL
MADHAV NAGAR
MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
948150283 |
| Fax |
|
| Email |
roshan.fernandes@manipal.edu |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE MANIPAL, MANIPAL ACADEMY OF HIGHER EDUCATION
UDUPI 576104
KARNATAKA
INDIA |
|
|
Primary Sponsor
|
| Name |
DR ROSHAN JOSEPH FERNANDES |
| Address |
DEPARTMENT OF CRITICAL CARE MEDICINE
KASTURBA MEDICAL COLLEGE MANIPAL |
| 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 ROSHAN JOSEPH FERNANDES |
KASTURBA HOSPITAL MANIPAL |
DEPARTMENT OF CRITICAL CARE FIRST FLOOR ICU1, ICU2, ICU 3
KASTURBA HOSPITAL .
MANIAPL
Udupi
KARNATAKA |
9481450283
roshan.fernandes@manipal.edu |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z66||Do not resuscitate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged above 18 years and referred for palliative care |
|
| ExclusionCriteria |
| Details |
1.Patients aged less than 18 years
2.Patients not referred to palliative care.
3.Patients discharged against medical advice
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mortality |
7 days after palliative medicine consultation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mechanical ventilatory support |
7 days after palliative consultation |
|
|
Target Sample Size
|
Total Sample Size="850"
Sample Size from India="850"
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)
|
10/08/2024 |
| 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="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
|
Palliative care deals with patients physical, spiritual and psychosocial needs, it performs accurate assessments related to patients’ illness and helps in managing them effectively. Admission to ICU imposes major burden on patients and family members both emotionally and financially and this worsens with increase in the length of icu stay and unnecessary life sustaining treatments.
This study is aimed at identifying the factors influencing palliative referral in critical care units, to explore factors contributing to medical futility, and burden of prolonged life sustaining treatment in icu, to optimise icu resource utilization with early referral to critical care units. As there is limited literature available on palliative care in Indian setups due to lack of end-of-life care policies, findings of our study will help contribute to the literature and evaluate if early referrals to palliative care can impact overall outcome critically ill patients . |