| CTRI Number |
CTRI/2025/11/096847 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
03/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Screening
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
PREDICT DELIRIUM TRIAL :Prevention of Delirium in Critically ill Patients by comparing Non-Pharmacological versus Pharmacological Techniques -A Randomised Controlled trial |
|
Scientific Title of Study
|
A Randomised Controlled Trial on Non-Pharmacological versus Pharmacological Interventions for Prevention of Delirium among Critically ill 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 |
Vanitha N |
| Designation |
ASSOCIATE CONSULTANT |
| Affiliation |
APOLLO SPECIALITY HOSPITAL |
| Address |
4th Floor ICU Complex , Department of Critical Care Medicine ,Apollo Speciality Hospital ,Jayanagar 3rd block ,Bangalore
Flat 002, Building 12, Shanthi park apartment ,Jayanagar 9th block ,Bangalore-560064
Bangalore
KARNATAKA
560011
India |
| Phone |
9916872121 |
| Fax |
|
| Email |
vp10vanitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vanitha N |
| Designation |
ASSOCIATE CONSULTANT |
| Affiliation |
NABH -Accrediated hospital |
| Address |
4th Floor ICU Complex , Department of Critical Care Medicine ,Apollo Speciality Hospital ,Jayanagar 3rd block ,Bangalore
121, Nisarga Nilaya , Hinnakki Village , Anekal Taluk ,Bangalore-562106
Bangalore Rural
KARNATAKA
560011
India |
| Phone |
9916872121 |
| Fax |
|
| Email |
vp10vanitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vanitha N |
| Designation |
ASSOCIATE CONSULTANT |
| Affiliation |
APOLLO SPECIALITY HOSPITAL |
| Address |
4th Floor ICU Complex , Department of Critical Care Medicine ,Apollo Speciality Hospital ,Jayanagar 3rd block ,Bangalore
121, Nisarga Nilaya , Hinnakki Village , Anekal Taluk ,Bangalore-562106
Bangalore
KARNATAKA
560011
India |
| Phone |
9916872121 |
| Fax |
|
| Email |
vp10vanitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Speciality Hospitals ,14th Cross road ,Dr Parvathamma Rajkumar road,near Madhavan park circle ,Jayanagar 3rd Block,Bangalore-560011 |
|
|
Primary Sponsor
|
| Name |
Apollo Speciality Hospital |
| Address |
14th Cross Road, 212,Dr Parvathamma Rajkumar Road ,near Madhavan Park circle,Jayanagar 3rd Block,Bangalore-560011 |
| 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 |
| Vanitha N |
Apollo Speciality Hospital |
Critical Care Unit,4th Floor ICU Complex, Department of Critical Care Medicine.
Bangalore
KARNATAKA |
9916872121
vp10vanitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non pharmacological techniques |
Along with standard practice of care Participants are provided with Eye masks,ear plugs,adequate ligtening control,education,re-orientation,early mobilization ,physiotherapy and family engagement twice daily during ICU stay |
| Intervention |
Pharmacological techniques |
Pharmacological group :
Tab.Melatonin (3mg)per oral once a day (especially in the night) during ICU stay
or
Inj.DEXMEDOTOMIDINE (2-7mcg/hr) IV infusion titrate to patients hemodynamics during ICU stay
either single or in combinations along with standard practice of care
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.minimum length of stay more than 24hrs
2.Awake intubated patients |
|
| ExclusionCriteria |
| Details |
1. Poor GCS ,Prior Dementia and cognitive impairement
2. already diagnosed encephalopathy
3.Not coopertive |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Comparing the effectiveness of Non-pharmacological versus pharmacological interventions for prevention of delirium among critically ill patients
2. To Estimate the frequency of occurence of Delirium in ICU |
1.During ICU Stay- 0,24hrs,48hrs,72hrs and
2. During discharge from ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of Mechanical ventilation
length of stay in ICU & Hospital stay
incidence of inadvertent catheter removal
ICU readmissions
All cause 30day mortality |
During ICU stay- 24hrs,48hrs,72hrs
During discharge from ICU
30 days telephonically |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="0"
Months="1"
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 is a common phenomenon occuring in 20-70% of hospitalized patients.Majoring of patients undergoing surgery and recurrent admissions due to chronic illness, polypharmacy and financial constraints cause lot distress to patients and family as well and are more for delirium which in turn cause more morbidities and mortality .Hence Prevention and early detection are crucial.All previous studies have reported the incidence and various methods for management of delirium ,there is a paucity of literature comparing these two potentially effective techniques for Delirium prevention. Hence we are planning to conduct this RCT in out tertiary care centre to compare the effectiveness of Nonpharmacological techniques versus pharmacological interventions for prevention of delirium among critically ill patients. This study will lead pathway for major studies on Delirium background |