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CTRI Number  CTRI/2021/04/032651 [Registered on: 08/04/2021] Trial Registered Prospectively
Last Modified On: 02/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To find out the proportion of patients admitted for surgery of hip fracture who develop delirium 
Scientific Title of Study   Incidence, Risk Factors and Outcome of Post-Operative Delirium in Elderly Patients Undergoing Hip Surgery A prospective observational study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Najitha A R 
Designation  Resident 
Affiliation  ASTERMIMS 
Address  Department of Anaesthesiology, Aster Mims, Calicut

Kozhikode
KERALA
673016
India 
Phone  09447308598  
Fax    
Email  najithapalath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Biju Sekhar 
Designation  Senior Consultant 
Affiliation  ASTERMIMS 
Address  Department of Anaesthesiology, Aster Mims, Calicut

Kozhikode
KERALA
673016
India 
Phone  09447308598  
Fax    
Email  biju.sekhar@asterhospital.com  
 
Details of Contact Person
Public Query  
Name  DR Najitha A R 
Designation  Resident 
Affiliation  ASTERMIMS 
Address  Department of Anaesthesiology Aster Mims , Calicut

Kozhikode
KERALA
673016
India 
Phone  09447308598  
Fax    
Email  najithapalath@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Najitha A R 
Address  Department of Anaesthesiology, Aster Mims, Calicut 
Type of Sponsor  Other [Self] 
 
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 Biju Sekhar  Aster Mims, Calicut  Operating room, Aster Mims, Govindapuram
Kozhikode
KERALA 		 9947270050

biju.sekhar@asterhospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Malabar Institute of Medical Sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Elderly patients above 60 years 
 
ExclusionCriteria 
Details  Preoperative history of schizophrenia, epilepsy, delirium, Alzheimer’s dementia, and other dementia
Patients with communication and listening impairment and severe auditory or visual disability
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the incidence of POD after hip surgery  From admission till discharge 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate risk factors associated with and outcome of postoperative delirium  From admission till discharge 
 
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)   20/04/2021 
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   nil  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [priyanka.pavithran@gmail.com].

  6. For how long will this data be available start date provided 01-02-2024 and end date provided 01-02-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   After obtaining informed consent the patients included in the study will be evaluated a day before surgery. Information about the demographics status and other clinical details will be recorded in a predefined proforma. preoperative assessment of the mental status will be done and those with delirium will be excluded. the included patients will be followed up in the postoperative period till discharge to look for onset of delirium. one month after the surgery patients will be contacted vi a phone to determine their survival status 
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