| CTRI Number |
CTRI/2024/12/077639 [Registered on: 04/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the occurrence of delirium in ICU patients using a delirium prediction tool. |
|
Scientific Title of Study
|
Evaluation of the accuracy of the predeliric tool in predicting delirium in critically ill adult patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhumathi M |
| Designation |
Senior Resident |
| Affiliation |
Bharati vidyapeeth deemed to be university medical college |
| Address |
Department of critical care medicine,Bharati Hospital and research centre,Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9750619780 |
| Fax |
|
| Email |
dr.madhumathimram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar Iyer |
| Designation |
HOD |
| Affiliation |
Bharati Hospital and Research Center,Pune |
| Address |
Department of critical care medicine,Bharati Hospital and research centre,Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9822051719 |
| Fax |
|
| Email |
shivkumar.iyer@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhumathi M |
| Designation |
Senior Resident |
| Affiliation |
Bharati Hospital and Research Center,Pune |
| Address |
Department of critical care medicine,Bharati Hospital and research centre,Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
9822051719 |
| Fax |
|
| Email |
dr.madhumathimram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Hospital and Research Centre,Pune-Satara Road, Pune, Maharashtra, India- 411043 |
|
|
Primary Sponsor
|
| Name |
Bharati Hospital and Research Centre,Pune |
| Address |
Bharati Hospital and Research Centre,Satara road, Katraj, Pune |
| Type of Sponsor |
Private medical college |
|
|
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 Madhumathi M |
Bharati Hospital and Research Center,Pune |
Room 216, second floor, Department of Critical Care Medicine, Bharati Hospital and Research Centre, Pune 411043
Pune
MAHARASHTRA |
9750619780
dr.madhumathimram@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
|
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 |
1. All Adult patients admitted in the ICU
2. Staying for more than 24 hours in the ICU |
|
| ExclusionCriteria |
| Details |
1. Delirium at the time of arrival
2. Patient less than 18 years of age |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Incidence of delirium |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| length of ICU stay, mortality |
7 days |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
15/12/2024 |
| 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="6"
Days="0" |
|
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
|
Delirium, a state of acute
confusion and altered consciousness, is common among ICU patients
and is associated with numerous adverse outcomes, including prolonged hospital
stays, increased morbidity and mortality, and higher healthcare costs.
Predicting delirium in the
intensive care unit (ICU) is crucial for several reasons. Early identification
of patients at risk for delirium allows for targeted interventions such as
optimizing sedation, minimizing medications that can exacerbate delirium, and
implementing delirium prevention protocols. Moreover, predicting delirium can
facilitate appropriate resource allocation and patient care planning,
ultimately improving patient outcomes and reducing the burden on healthcare
systems. The goal of this study was to utilise the PRE-DELIRIC
tool on admission to predict the occurrence of delirium during the course of
ICU stay using the CAM-ICU method for the diagnosis of delirium.
The need of the hour thus lies in early detection and
management of delirium thereby preventing adverse outcomes and improving the
overall quality of patient care and the long-term aftermath.
|