| CTRI Number |
CTRI/2024/11/076220 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
The connection between deciding if further medical treatment is pointless and the organ failure score in a population of ICU patients without cancer. |
|
Scientific Title of Study
|
Futility decision and its association with sequential organ failure
assessment score in non-cancer ICU patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version: 1.0 dated 05/09/2024 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Samprathi |
| Designation |
Consultant, Critical Care Services |
| Affiliation |
Narayana Health |
| Address |
258/A, Hosur Road, Anekal Taluk, Bommasandra Industrial Area, Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
8056738436 |
| Fax |
|
| Email |
abhisamprati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Samprathi |
| Designation |
Consultant, Critical Care Services |
| Affiliation |
Narayana Health |
| Address |
258/A, Hosur Road, Anekal Taluk, Bommasandra Industrial Area, Bengaluru
KARNATAKA
560099
India |
| Phone |
8056738436 |
| Fax |
|
| Email |
abhisamprati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Samprathi |
| Designation |
Consultant, Critical Care Services |
| Affiliation |
Narayana Health |
| Address |
258/A, Hosur Road, Anekal Taluk, Bommasandra Industrial Area, Bengaluru
KARNATAKA
560099
India |
| Phone |
8056738436 |
| Fax |
|
| Email |
abhisamprati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana Health City, 258/A Bommasandra Industrial area, Hosur Road, Bengaluru, 560099 |
|
|
Primary Sponsor
|
| Name |
Dr Abhishek Samprathi |
| Address |
Narayana Health City, 258/A Bommasandra Industrial area, Hosur Road, Bengaluru, 560099 |
| 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 Abhishek Samprathi |
Narayana Health |
2nd floor,MICU,Dept of Critical Care, Mazumdar Shaw Medical Centre, 258-A, Hosur Road Anekal, Taluk, Bommasandra Industrial Area, Bengaluru, Karnataka 560099
Bangalore
KARNATAKA |
8056738436
abhisamprati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) All ICU patients in whom continuing medical care was deemed futile by the Critical care team will be recruited as Cases.
2) All patients who died during the same period who were not deemed futile and died in ICU will be recruited as Controls.
|
|
| ExclusionCriteria |
| Details |
1. Aged above 18 years
2. Incomplete data
3. Futility decision within 5 days of ICU admission
4. ICU admission duration less than 5 days
5. Decision of withhold or withdraw of life sustaining therapies initiated by other than critical care team like family members, other clinicians. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To know the association between the decision of futility care with the SOFA score days before the futility decision.
|
1) D0: At ICU admission
2)De: On the day of event (either futility decision in cases group or death in control group)
3) De-3: Three-days prior to the event
4) De-5: Five-days prior to the event |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/11/2024 |
| Date of Study Completion (India) |
01/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/01/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Rapid technological development in the recent decades have increased the lifespan of critically ill patients in intensive care units (ICU). However, this might also lead to futile medical care. Medical futility remains a controversial ethical term and broadly it means to be incapable of producing any useful result. Many factors contribute to futile medical care like social, occupational, organizational and sometimes financial status also in developing countries. Other than these, individual factors like sense of guilt, grief, lack of correct information, fear of a plausible legal action and the patient family’s response contribute to the futile care. We aimed to study to find out objectivity in the decision making by critical care physicians for futility care through the ICU severity score SOFA score. |