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CTRI Number  CTRI/2024/06/068334 [Registered on: 05/06/2024] Trial Registered Prospectively
Last Modified On: 04/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Factors affecting mortality of elderly patients admitted in surgical intensive care unit  
Scientific Title of Study   A prospective observational study of factors affecting the mortality of elderly patients admitted to the surgical intensive care unit 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ADAPA DEEPTHI MOHITHA 
Designation  Junior resident 
Affiliation  Lokmanya Tilak Medical College and General hospital 
Address  Department OF Aneasthesia fourth floor College Building LTMMC College SION Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7989457188  
Fax    
Email  deepthimohitha0803@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR.RUCHI JAIN 
Designation  Assistant professor  
Affiliation  LOKMANYA TILAK MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  Department of Aneasthesiology fourth floor college building LTMMC college Sion Mumbai


MAHARASHTRA
400022
India 
Phone  9619419983  
Fax    
Email  ruchiajain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ADAPA DEEPTHI MOHITHA 
Designation  JUNIOR RESIDENT 
Affiliation  LOKMANYA TILAK MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  Department of Aneasthesiology Fourth Floor College Building LTMMC College SION Mumbai

Mumbai
MAHARASHTRA
400022
India 
Phone  7989457188  
Fax    
Email  deepthimohitha0803@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya Tilak Medical College and General hospital SION MUMBAI PINCODE-400022 MAHARASTRA INDIA 
 
Primary Sponsor  
Name  LOKMANYA TILAK MEDICAL COLLEGE AND MUNICIPAL HOSPITAL 
Address  Department of Aneasthesiology Fourth Floor College Building SION MUMBAI-400022 Maharastra 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
DR RUCHI JAIN  Department of Aneasthesiology Fourth Floor College Building Sion MUMBAI-400022 Maharastra India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Adapa Deepthi Mohitha  LOKMANYA TILAK MEDICAL COLLEGE AND GENERAL HOSPITAL  SICU,3RD floor,hospital builiding ,Sion,Mumbai-400022 Department of Aneasthesia.
Mumbai
MAHARASHTRA 
07989457188

deepthimohitha0803@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Lokmanya Tilak Municipal Medical College,Sion,mumbai-400022  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z488||Encounter for other specified postprocedural aftercare,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All the patients aged 65 years and above admitted to surgical ICUs for a minimum duration of 24 hours  
 
ExclusionCriteria 
Details  .Patients discharged against medical advice
.Patients transferred to other hospital
.The patients who are admitted to the neurosurgery,trauma and cardiac ICUs
.Patients who do not consent to partake in the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To identify factors affecting the mortality of elderly patients admitted to SICU
 
In icu,in Hospital 28 days 
 
Secondary Outcome  
Outcome  TimePoints 
• To calculate the mortality rate of elderly patients admitted to the SICU
• To investigate the factors affecting the length of ICU stay
• To describe the system-wise disease spectrum in elderly patients admitted to the SICU
 
In icu,in Hospital 28 days
 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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)   15/06/2024 
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="4"
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  

In India, geriatric medicine is still an evolving field, and the elderly population is expected to increase to 319 million by 2050. However, addressing the healthcare needs of this growing number of vulnerable and heterogeneous populations is a big challenge. Most of the studies on the elderly population are from Western countries; however, data on the outcomes of elderly patients in Indian intensive care units (ICU) is limited. Most of this data is from mixed medical and surgical intensive care units and does not cover the issues related to a perioperative setting. Elderly patients undergoing surgery have additional stressors along with the multiple co-morbidities that accompany old age, that may affect that outcome. Concerns like frailty, comorbidities, poly-pharmacy come up even before admission into the unit. Physiological changes, including immunosenescence -a term used to describe age-related immune dysregulation and alterations in respiratory capacity (loss of lung elasticity, reduced muscle strength, altered sensitivity of respiratory centres to hypoxia and/or hypercapnia) contribute to increased risk of susceptibility to pathogens, viral reactivation, respiratory failure, and finally death. Frail patients have reduced resilience, making their recovery more difficult and prolonging their hospital length of stay. Pre-existing cognitive impairment represents a decisive risk factor for delirium within the ICU, associated with increased mortality and further cognitive decline. Advances in surgical technique and intensive care have significantly reduced the mortality rates of critically ill surgical patients. However, the burden of critically ill surgical patients is increasing as more elderly patients are seeking surgical treatment. Lack of data hinders informed decision making by the clinical team and the family. A better understanding of risk factors associated with mortality of surgical ICU patients is of great importance for treatment evaluation, patient triage and resource allocation. Hence we planned a study to investigate predictors of in-ICU mortality in elderly patients admitted to the surgical ICU, ,to assess the system wise disease spectrum of elderly patients admitted to surgical ICU, to determine mortality in elderly patients admitted to the surgical ICU: during ICU stay, in-hospital and at 28 days.


 
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