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CTRI Number  CTRI/2025/12/099826 [Registered on: 24/12/2025] Trial Registered Prospectively
Last Modified On: 06/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   how common is delirium in ICU Patients and how does it affect Their Recovery 
Scientific Title of Study   Prevalence and outcomes of delirium in medical and surgical ICUs : A prospective study. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amanpreet Kaur 
Designation  pharmD pb Intern 
Affiliation  Indus International Hospital 
Address  Department of clinical trial.Indus International hospital Chandigarh Ambala Highway Derabassi SAS Nagar Rupnagar PUNJAB 140507 India
Department of clinical trialIndus International hospital Chandigarh Ambala Highway Derabassi SAS Nagar Rupnagar PUNJAB 140507 India
Rupnagar
PUNJAB
140507
India 
Phone  8708813335  
Fax    
Email  amanpreetkaur87088@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parminder Kaur 
Designation  Medical Superintendent 
Affiliation  Indus International Hospital 
Address  Admin Department Chandigarh Indus International hospital Ambala Highway Derabassi SAS Nagar Rupnagar PUNJAB 140507 India
Admin Department Chandigarh Indus International hospital Ambala Highway Derabassi SAS Nagar Rupnagar PUNJAB 140507 India
Rupnagar
PUNJAB
140507
India 
Phone  8872735888  
Fax    
Email  msiih@indushospitals.com  
 
Details of Contact Person
Public Query  
Name  Avantika Chandra 
Designation  manager clinical Research department 
Affiliation  Indus International Hospital 
Address  Department of clinical trial.Indus International hospital Chandigarh Ambala Highway Derabassi SAS Nagar Rupnagar PUNJAB 140507 India
Department of clinical trial.Indus International hospital Chandigarh Ambala Highway Derabassi SAS Nagar Rupnagar PUNJAB 140507 India
Rupnagar
PUNJAB
140507
India 
Phone  7991451277  
Fax    
Email  avantikabiotech2017@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Indus International Hospital 
Address  Indus International hospital Ambala-chandigarh highway derabassi SAS Nagar Rupnagar 140507 Punjab India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amanpreet kaur  Indus International Hospital  Surgical and Medical ICUs. Indus International hospital Chandigarh Ambala Highway Derabassi SAS Nagar Rupnagar PUNJAB 140507 India
Rupnagar
PUNJAB 		 8708813335

amanpreetkaur87088@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indus International Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  adult patient 18 and more than 18
Admitted to the intensive care unit
Diagnosed with delirium, using cam and RAAS
 
 
ExclusionCriteria 
Details  Pediatric patient less than 18.
Non-ICU patient.
Patients with dementia as the primary diagnosis .
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Early Detection Helps Improve Outcome Impact of Interventions
Patients who received early non-pharmacologic and pharmacologic treatment had
Role of Antipsychotics 		 On first day check the Patient by performing RAAS tool .
2nd day performed Cam ICU .
follow up patient at Discharge Time 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   31/12/2025 
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="6"
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   Delirium is an acute and fluctuating disturbance in attention, awareness, and cognition, commonly observed in critically ill patients admitted to Intensive Care Units (ICUs). It develops over hours to days and is strongly associated with underlying physiological stress, severe illness, and exposure to sedative or analgesic medications. ICU delirium affects both medical (MICU) and surgical (SICU) populations and remains one of the most frequent complications in critically ill adults. According to the National Institute for Health and Care Excellence (NICE), delirium significantly contributes to prolonged hospitalization, increased healthcare costs, higher mortality, and long-term cognitive impairment . 
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