| CTRI Number |
CTRI/2026/01/101380 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
15/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To study the causes and symptoms of sudden confusion in elderly patients who come to a tertiary care hospital |
|
Scientific Title of Study
|
To evaluate the clinicoetiological profile of acute confusional state in elderly patients in tertiary care centre |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gurinder Mohan |
| Designation |
Professor and Hod |
| Affiliation |
SGRDIMSR,AMRITSAR |
| Address |
#81,Tilak nagar, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9815341556 |
| Fax |
|
| Email |
gmohan1.med@sgrdimsr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurinder Mohan |
| Designation |
Professor and Hod |
| Affiliation |
SGRDIMSR,AMRITSAR |
| Address |
#81,Tilak nagar, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9815341556 |
| Fax |
|
| Email |
gmohan1.med@sgrdimsr.in |
|
Details of Contact Person
Public Query
|
| Name |
Kirandeep Kaur |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Dass Institute of Medical Sciences And Research, Amritsar |
| Address |
House No.63, Nagina Avenue Majitha Road, Amritsar, 143001
Amritsar
PUNJAB
143001
India |
| Phone |
6284934129 |
| Fax |
|
| Email |
pannukirandeep9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Medicine
Sri Guru Ram Dass Institute of Medical Sciences and Research, Vallah, Amritsar,Punjab,India, 143001 |
|
|
Primary Sponsor
|
| Name |
Department of Medicine |
| Address |
Sri Guru Ram Dass Institute of Medical Sciences and Research Vallah Amritsar,Punjab,India,143001 |
| 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 Gurinder Mohan |
Sri Guru Ram Dass Institute of Medical Sciences and Research, Vallah, Amritsar |
Post graduates room Department of medicine, Third floor, Unit 1 , Sri Guru Ram Dass institute of medical sciences,Vallah, Amritsar ,143001
Amritsar
PUNJAB |
9815341556
gmohan1.med@sgrdimsr.in |
|
|
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: G02||Meningitis in other infectious andparasitic diseases classified elsewhere, (2) ICD-10 Condition: E87||Other disorders of fluid, electrolyte and acid-base balance, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient not alert to time place and person
2. Decreased responsiveness to verbal and physical stimulation
3. Difficult to arouse
4. Unable to remain awake or conversant
5. Presents with hallucinations, confusion, bizarre or inappropriate behaviour |
|
| ExclusionCriteria |
| Details |
1. Age less than 60
2. Psychiatric disease
3. Head trauma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the most frequent causes of acute confusional state in elderly |
Two days study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association between the etiological factor and duration of hospital stay |
Two days study |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
27/01/2026 |
| 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 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
|
Acute confusinal state is a state of altered attention, awareness, cognition. It is more common in elderly population with various studies reporting in 40% hospital admissions over 70 years of age. Adverse outcomes include prolonged hospital stay, increased risk of complications or mortality. Some other causes of this state include sepsis, pneumonia, UTI, viral infections, encephalitis, meningitis, cerebral abscess, benzodiazepines, anticholinergics, analgesics, anti parkinson, carbon monoxide poisoning, acute alcohol intoxication, hypoxia, hyper or hypoglycemia, hypo or hypernatremia. |