| 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
|
|
|
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.
|