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CTRI Number  CTRI/2024/02/062519 [Registered on: 12/02/2024] Trial Registered Prospectively
Last Modified On: 07/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Burden of intensive care survivors on Critical Care Unit and family. 
Scientific Title of Study   ICU Survivors Follow up: Post Intensive Care Syndrome (PICS) Burden on Critical Care Unit and Family. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Banani Poddar 
Designation  Professor and head of department of critical care medicine 
Affiliation  Sanjay Gandhi Post Graduate Institute Of Medical Sciences 
Address  Room no-1, second floor, Department of critical care medicine, SGPGIMS, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904729  
Fax  05222668017  
Email  bananip@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Banani Poddar 
Designation  Professor and head of department of critical care medicine 
Affiliation  Sanjay Gandhi Post Graduate Institute Of Medical Sciences 
Address  Room no-1, second floor, Department of critical care medicine, SGPGIMS, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904729  
Fax  05222668017  
Email  bananip@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Arnavjyoti Das 
Designation  Student of department of critical care medicine 
Affiliation  Sanjay Gandhi Post Graduate Institute Of Medical Sciences 
Address  CCM ICU 2, Department of Critical Care Medicine, Main hospital, SGPGI campus Lucknow
Not applicable.
Lucknow
UTTAR PRADESH
226014
India 
Phone  8004907745  
Fax  05222668017  
Email  alreadyajd@gmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow - 226014 
 
Primary Sponsor  
Name  NIL 
Address  Not applicable. 
Type of Sponsor  Other [NIL] 
 
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 
Banani Poddar  Sanjay Gandhi Post Graduate Institute of Medical Sciences  Department of Critical Care Medicine, SGPGI, Lucknow - 226014
Lucknow
UTTAR PRADESH 
8004904729

bananip@sgpgi.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Comittee, SGPGI, Lucknow  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Family members of patients discharged from ICU 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Family members of:
a. Patients who are discharged from ICU with Cerebral Performance Category Scale Score (CPCSS) less than or equals to 4.
b. Patients who are 18-65 years old.
 
 
ExclusionCriteria 
Details  (any of the following)
Family members:
a. Of terminally ill patients discharged for home comfort care.
b. Of patients who are not capable of following up due to socioeconomic or manpower related issues.
c. Of patients with ICU stay less than 7 days.
d. Of patients with pre-illness CPCSS more than or equals to 3.
e. Who are unable to comprehend the ‘Expenditure chart’.
f. Of patients who are Discharged Against Medical Advice or transferred to another institution.
g. Of patients with more than 1 time readmission in CCM during the same course of illness.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the psychological and physical burden of PICS on family.  2-3 months after discharge from hospital. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the financial burden of PICS on the family.
2. To assess the burden of ICU survivors on department of Critical Care Medicine, SGPGIMS, Lucknow.
3. To attempt an assessment of the expected expenditure at 2 to 3 months for a particular severity of PICS disability. 
Up to 2-3 months after discharge from hospital. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   17/02/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

Intensive care unit (ICU) survivors often face a myriad of physical, psychological, and cognitive challenges, collectively known as post-intensive care syndrome (PICS). This complex condition not only impacts the individual patient but also extends to their families, known as PICS-F and exerts a significant burden on the critical care unit during post-discharge care, which plays a crucial role in managing the long-term consequences of critical illness and improving patient outcomes. Understanding the burden of PICS on both the ICU and the family is essential for developing effective interventions and optimizing post-ICU follow-up strategies.

Family members of the consecutive patients who are discharged from the ICU, are to be studied on, after considering the following inclusion and exclusion criteria:

Inclusion criteria:

Family members of:

a.      a. Patients who are discharged from ICU with Cerebral Performance Category Scale Score (CPCSS) less than or equals to 4.

b.     b. Patients who are 18-65 years old.

Exclusion criteria: (any of the following)

Family members:

a. Of terminally ill patients discharged for home comfort care.

b.     b. Of patients who are not capable of following up due to socioeconomic or manpower related issues.

c.      c. Of patients with ICU stay less than 7 days.

d.     d. Of patients with pre-illness CPCSS more than or equals to 3.

e.      e. Who are unable to comprehend the ‘Expenditure chart’.

f.      f. Of patients who are Discharged Against Medical Advice or transferred to another institution.

g.     g. Of patients with more than 1 time readmission in CCM during the same course of illness.

     Duration of study: 1 year 6 months.

Work plan:

After discharge from hospital, the ICU survivors will be asked to follow up in the CCM department at least once after 1 month and once after 2-3 months. The family members will be counselled regarding the possible post hospital course as well as they will be explained about the purpose of the study. They will be provided with an ‘expenditure chart’, a specially made chart exclusive for this study, to keep track of their expenses during the follow up period. The most important family member will also be interviewed during the final follow up visit for assessment of physical and psychological impact of PICS-F by Health Related Quality of Life (HRQoL-14) Questionnaire originally formulated by Centre of Disease Control (CDC). Thus, the physical, psychological and economical burden of PICS on family (PICS-F) will be holistically viewed. The PICS-F, thus understood, will be stacked against the disability of the ICU survivors in terms of CPCSS and Clinical Frailty Score (CFS) and compared. During the follow up, the patients will be attended to their proper needs and the time and manpower utilisation from CCM department, SGPGIMS during individual follow up visit will be documented as a novel index specially formulated for this study, named the ‘man-time index’, which should reflect the burden of ICU survivors on the critical care unit.

Ethical issues:

This is an observational study which involves the follow up visits of the ICU survivors after discharge. This will not affect the routine post discharge care of the patient. The logistic problems faced by the families of following up to a particular critical care unit are unavoidable, mostly because of the distances between their residence and the critical care unit are significant. This is nullified by encouraging the family to synchronise the multi-disciplinary follow up visits to a single day as ICU survivors often has multi-disciplinary issues for which follow up visits to respective disciplines are required. There are no obvious ethical issues and interventions are planned based on this data. Informed consent is taken for each inclusion.   

Statistical Analysis:

As there is no adequate literature available to guide this study, this study can be considered to be a pilot study. Statistical analysis to be performed using software “Statistical package for social sciences version 23 (SPSS-23) and MedCalc.

 
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