| CTRI Number |
CTRI/2020/12/029717 [Registered on: 10/12/2020] Trial Registered Prospectively |
| Last Modified On: |
09/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISION OF INCIDENCE OF POST INTENSIVE CARE SYNDROME(PICU-SYNDROME) THAT COMPRISES OF IMPAIREMENT IN COGNITION, PSYCHOLOGICAL HEALTH, AND PHYSICAL FUNCTION OF INTENSIVE CARE UNIT (ICU) SURVIVORS HAVING STAY TIME LESS THAN SEVEN DAYS Vs HAVING GREATER THAN SEVEN DAYS UNDER DIFFERENT SCALES. |
|
Scientific Title of Study
|
COMPARISION OF INCIDENCE OF POST INTENSIVE CARE SYNDROME(PICU-SYNDROME)IN ICU SURVIVOR HAVING STAY TIME LESS THAN SEVEN DAYS Vs HAVING GREATER THAN SEVEN DAYS |
| Trial Acronym |
PICU-SYNDROME |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JITESH KUMAR YADAV |
| Designation |
Junior Resident |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES BHU |
| Address |
SIR SUNDAR LAL HOSPITAL DEPARTMENT OF
ANAESTHESIOLOGY BHU VARANASI (UTTAR PRADESH)
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9889546134 |
| Fax |
|
| Email |
jiteshyadav08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PUSHKAR RANJAN |
| Designation |
PROFESSOR |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES BHU |
| Address |
SIR SUNDAR LAL HOSPITAL DEPARTMENT OF
ANAESTHESIOLOGY BHU VARANASI (UTTAR PRADESH)
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415986684 |
| Fax |
|
| Email |
pushkarranjanbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr BIKRAM GUPTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
INSTITUTE OF MEDICAL SCIENCES BHU |
| Address |
SIR SUNDAR LAL HOSPITAL DEPARTMENT OF
ANAESTHESIOLOGY BHU VARANASI (UTTAR PRADESH)
Varanasi
UTTAR PRADESH
221005
India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8400100128 |
| Fax |
|
| Email |
bikramgupta03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of medical sciences, Banaras Hindu University.. Lanka, Varanasi, Uttar Pradesh..
Varanasi-221005 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr JITESH KR YADAV |
Institute Of Medical Science, Banaras Hindu University |
Intensive Care Unit (ICU) Department Of Anesthesiology Sir Sundarlal Hospital And Trauma Center.
Varanasi
UTTAR PRADESH |
9889546134
jiteshyadav08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of medical sciences, Banaras Hindu University Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not Applicable. |
Not Applicable. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 18 and 60 years. 2.Patient discharged from icu having period less than 7 days
3.Patient discharged from icu having period more than 7 days |
|
| ExclusionCriteria |
| Details |
1.Patients refusal
2.Neuromuscular disorders
3.Any type of stroke
4.Quadriplegia due spinal syndrome
5.Patients in whom muscle strength not assessed because of prolonged delirium or failure to awake 5.Language barrier
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To gain insight in need for care and rehabilitation intervention. |
Patients icu stay time and After 2 week discharge from icu. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/12/2020 |
| 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="1"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective randomized parallel group study were patient population will be divided in two groups and we will be comparing Post icu syndrome(PICU-SYNDROME) That comprises of impairment in cognition, psychological health, and physical function of the intensive care unit (ICU) survivors Having stay time less than seven days Vs having greater than seven days-[PICU-SYNDROME).Under different scales. |