| CTRI Number |
CTRI/2024/09/074243 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To understand antibiotic prescription in patients at end-stage of illness |
|
Scientific Title of Study
|
To understand the antimicrobial prescription patterns in patients with terminal or life-limiting illness in intensive care unit- An 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 |
Sonali Vadi |
| Designation |
Consultant |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
First floor, Department of ICU, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri (west), Mumbai Mumbai Mumbai MAHARASHTRA 400053 India |
| Phone |
9090909090 |
| Fax |
|
| Email |
sonali.vadi@kokilabenhospitals.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sonali Vadi |
| Designation |
Consultant |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
First floor, Department of ICU, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri (west), Mumbai Mumbai
MAHARASHTRA 400053 India |
| Phone |
9090909090 |
| Fax |
|
| Email |
sonali.vadi@kokilabenhospitals.com |
|
Details of Contact Person Public Query
|
| Name |
Sonali Vadi |
| Designation |
Consultant |
| Affiliation |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
First floor, Department of ICU, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri (west), Mumbai Mumbai
MAHARASHTRA 400053 India |
| Phone |
9090909090 |
| Fax |
|
| Email |
sonali.vadi@kokilabenhospitals.com |
|
|
Source of Monetary or Material Support
|
| Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri (West), Mumbai- 400053, India |
|
|
Primary Sponsor
|
| Name |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
| Address |
First floor, Department of ICU, Andheri (west), Mumbai 400053, Maharashtra, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Sonali Vadi |
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute |
First floor, Department of ICU, Andheri (west), Mumbai Mumbai MAHARASHTRA |
9090909090
sonali.vadi@kokilabenhospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Academics (IEC-A) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
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. Adult ICU
2. Age more than 18 years
3. All genders
4. Patients with terminal or life-limiting illness
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand the antimicrobial prescription patterns in patients with terminal or life-limiting illness in intensive care unit |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
1 year |
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
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)
|
03/10/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The general goal of antimicrobial therapy is to increase patient’s survival and cure infectious diseases. Because antimicrobial agents are unable to alter the progression of underlying diseases or rather sometimes can prolong suffering in patients at the end-of-life, the goal of prolonging life should be weighed against the risk of prolonging suffering. Thus, the goal of antimicrobial therapy shifts from improving survival to symptom control with a shift in the goal of care from cure to palliation. The goal of antimicrobial therapy for terminal patients at an early stage can include symptom control and improvement in survival while maintaining the quality of life. Antimicrobials however do not change the natural course of disease. Also, no difference in frequencies of documented symptoms with the use of antimicrobials was seen in a retrospective study at end-of-life.
We do not have information from the Indian subcontinent. Results of this audit should serve as a living document for re-visiting antimicrobial prescription practices by physician prescribers and set up antimicrobial stewardship guidelines for terminally ill patients such that these can be viewed as aggressive care in end-of-life situations. |