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CTRI Number  CTRI/2024/12/078688 [Registered on: 27/12/2024] Trial Registered Prospectively
Last Modified On: 12/12/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Morbidity and Mortality among Critical Ill Patients on Life sustaining Treatment. 
Scientific Title of Study   Six Month Morbidity and Mortality among Intensive Care Unit Patients on life sustaining therapy 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Hemal Navin Shah 
Designation  Senior Resident 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  Department of Critical Care Medicine, Mahatma Gandhi Hoapital and Medical College, RICCO industrial area, Sitapura, Jaipur

Jaipur
RAJASTHAN
302033
India 
Phone  8459403121  
Fax    
Email  hemalnavinshah@gmial.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anand Jain 
Designation  Assistant Professor 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  Department of Organ Transplant and Critical Care, Mahatma Gandhi Hospital and Medical College, RICCO Industrial Area, Sitapura, Jaipur

Jaipur
RAJASTHAN
302033
India 
Phone  8459403121  
Fax    
Email  dr.akjain1983@gmail.com  
 
Details of Contact Person
Public Query  
Name  Hemal Navin Shah 
Designation  Senior Resident 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  Department of Critical Care Medicine, Mahatma Gandhi Hoapital and Medical College, RICCO industrial area, Sitapura, Jaipur


RAJASTHAN
302033
India 
Phone  8459403121  
Fax    
Email  hemalnavinshah@gmial.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Hospital and Medical College, RIICO industrial area, Sitapura, Jaipur, Rajasthan, 302033, India 
 
Primary Sponsor  
Name  Hemal Navin Shah 
Address  Department of Critical Care Medicine, RICCO industrial area, Sitapura, Jaipur 302033, Rajasthan, India 
Type of Sponsor  Private medical college 
 
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 Hemal Shah  Mahatma Gandhi Medical College and Hospital  Department of Critical Care Medicine, RICCO industrial area, Sitapura, jaipur 302033
Jaipur
RAJASTHAN 		 08459403121

hemalnavinshah@gmial.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of the Ethics Committee Mahatma Gandhi Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R098||Other specified symptoms and signsinvolving the circulatory and respiratory systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adults who were admitted to either medical or surgical ICU patients for a minimum of 3 consecutive days and required life-sustaining therapy.
 
 
ExclusionCriteria 
Details  Patients below the age of 18 years.
Patients whose long-term follow-up was not possible.
Incarcerated patients, enrolment in the study for previous ICU admission, neurosurgical and trauma patients that needed ICU admission were excluded.
Patients who were unfit for consenting and no legally acceptable relatives were available for consenting.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of survival and functional outcomes in critically ill patients requiring life-sustaining treatment.  At discharge and 6 months after the discharge 
 
Secondary Outcome  
Outcome  TimePoints 
Validation of Charlson comorbidity index and APACHE II score   At the time of admission and 48 hours after the ICU admission 
 
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)   01/01/2025 
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="1"
Months="0"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) -  data can be accessed on the request on the email address hemalnavinshah@gmail.com

  6. For how long will this data be available start date provided 12-01-2025 and end date provided 28-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Patients who survive critical illnesses requiring life-sustaining therapy in intensive care unit (ICU) experience immense difficulties in physical, psychological and cognitive functions. Majority research focuses on immediate outcomes with limited evidence on long-term outcomes of such patients.

Objective is to study the six-month mortality and morbidity among critically ill patients requiring life sustaining therapy.

It is a prospective, single centre, cohort study medical or surgical ICU patients admitted to ICU for a minimum of 3 consecutive days and required life sustaining therapy in terms of mechanical ventilation for 48 hours or vasopressor infusion for 24 hours or both. Cognitive and physical function outcomes at baseline (1-month before the admission) and at six months were noted. Six-month mortality rate and return to normal baseline function were assessed.

240 patients enrolled. All survivors had returned to their place of residence. Implementing cognitive and physical rehabilitation in such patients is essential to achieve optimal outcomes after discharge from ICU.

 
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