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CTRI Number  CTRI/2024/03/063860 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To study proportion of patients with stroke admitted in icu developing delirium(a form of depressed consciousness with confused state of mind) and observing how it affetcts clinical outcome of these subset of patients . 
Scientific Title of Study   Incidence of delirium in acute stroke patients admitted in ICU and its impact on clinical outcomes:A prospective observational study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VIVEK VISHAL 
Designation  DrNB resident 
Affiliation  Max Super Speciality Hospital,Saket,New,Dehi 
Address  6th Floor MICU,West Block,Department of Critical Care Medicine,Max Super Speciality Hospital,Press Enclave Road,Saket,New Delhi.

South
DELHI
110017
India 
Phone  9359271359  
Fax    
Email  drvivekvishal84@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DEVEN JUNEJA 
Designation  DIRECTOR 
Affiliation  Max Super Speciality Hospital,Saket,New,Dehi 
Address  6th Floor MICU,West Block,Department of Critical Care Medicine,Max Super Speciality Hospital,Press Enclave Road,Saket,New Delhi.

South
DELHI
110017
India 
Phone  9818290380  
Fax    
Email  deven.juneja@maxhealthcare.com  
 
Details of Contact Person
Public Query  
Name  DEVEN JUNEJA 
Designation  DIRECTOR 
Affiliation  Max Super Speciality Hospital,Saket,New,Dehi 
Address  6th Floor MICU,West Block,Department of Critical Care Medicine,Max Super Speciality Hospital,Press Enclave Road,Saket,New Delhi.

South
DELHI
110017
India 
Phone  9818290380  
Fax    
Email  deven.juneja@maxhealthcare.com  
 
Source of Monetary or Material Support  
Max Super Speciality Hoapital,Saket,New Delhi. 
 
Primary Sponsor  
Name  Vivek Vishal 
Address  Department of Critical Care Medicine,Max Super Speciality Hoapital,Press Enclave Road,Saket,New Delhi-110017. 
Type of Sponsor  Research institution and hospital 
 
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 Vivek Vishal  Max Super Speciality Hospital,Saket,New Delhi.  Stroke ICU,2nd floor,West Block,Department of Critical Care Medicine,Max Super Speciality Hospital,Press Enclave road,Saket,New Delhi--110017.
South
DELHI 		 9359271359

drvivekvishal84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Max Healthcare Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I610||Nontraumatic intracerebral hemorrhage in hemisphere, subcortical, (2) ICD-10 Condition: I611||Nontraumatic intracerebral hemorrhage in hemisphere, cortical, (3) ICD-10 Condition: I612||Nontraumatic intracerebral hemorrhage in hemisphere, unspecified, (4) ICD-10 Condition: I613||Nontraumatic intracerebral hemorrhage in brain stem, (5) ICD-10 Condition: I613||Nontraumatic intracerebral hemorrhage in brain stem, (6) ICD-10 Condition: I615||Nontraumatic intracerebral hemorrhage, intraventricular, (7) ICD-10 Condition: I616||Nontraumatic intracerebral hemorrhage, multiple localized, (8) ICD-10 Condition: I618||Other nontraumatic intracerebral hemorrhage, (9) ICD-10 Condition: I619||Nontraumatic intracerebral hemorrhage, unspecified, (10) ICD-10 Condition: I600||Nontraumatic subarachnoid hemorrhage from carotid siphon and bifurcation, (11) ICD-10 Condition: I601||Nontraumatic subarachnoid hemorrhage from middle cerebral artery, (12) ICD-10 Condition: I602||Nontraumatic subarachnoid hemorrhage from anterior communicating artery, (13) ICD-10 Condition: I603||Nontraumatic subarachnoid hemorrhage from posterior communicating artery, (14) ICD-10 Condition: I604||Nontraumatic subarachnoid hemorrhage from basilar artery, (15) ICD-10 Condition: I605||Nontraumatic subarachnoid hemorrhage from vertebral artery, (16) ICD-10 Condition: I606||Nontraumatic subarachnoid hemorrhage from other intracranial arteries, (17) ICD-10 Condition: I607||Nontraumatic subarachnoid hemorrhage from unspecified intracranial artery, (18) ICD-10 Condition: I607||Nontraumatic subarachnoid hemorrhage from unspecified intracranial artery, (19) ICD-10 Condition: I608||Other nontraumatic subarachnoid hemorrhage, (20) ICD-10 Condition: I609||Nontraumatic subarachnoid hemorrhage, unspecified, (21) ICD-10 Condition: I629||Nontraumatic intracranial hemorrhage, unspecified, (22) ICD-10 Condition: I630||Cerebral infarction due to thrombosis of precerebral arteries, (23) ICD-10 Condition: I631||Cerebral infarction due to embolism of precerebral arteries, (24) ICD-10 Condition: I632||Cerebral infarction due to unspecified occlusion or stenosis of precerebral arteries, (25) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, (26) ICD-10 Condition: I634||Cerebral infarction due to embolism of cerebral arteries, (27) ICD-10 Condition: I635||Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries, (28) ICD-10 Condition: I638||Other cerebral infarction, (29) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Age ≥18years
2. Diagnosis of stroke confirmed by CT or MRI
(IS and HS)
3. Clinical onset of stroke in previous 72
hours
4. NIHSS ≥1
 
 
ExclusionCriteria 
Details  1. Patients refusal
2. RASS less than minus 3
3. H/O trauma
4. H/O psychiatric disorder
5. Previous diagnosis of dementia
6. Transient Ischaemic Attack(TIA)
7. Cerebral Venous Thrombosis(CVT)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Incidence of delirium  Will be observed till patient is in ICU 
 
Secondary Outcome  
Outcome  TimePoints 
1.All cause ICU mortality
2.Length of stay in ICU
3. Modified Rankin Scale at the time of discharge from ICU
4.Total length of stay in hospital
 		 Will be observed till patient is admitted in hospital. 
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
Final Enrollment numbers achieved (Total)= "107"
Final Enrollment numbers achieved (India)="107" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/03/2024 
Date of Study Completion (India) 30/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Delirium is one of the common complications observed in acute stroke  patients admitted in ICU  and has significant effect on morbidity,mortality,overall length of ICU stay and long term cognitive impairement.Diagnosis of delirium is often missed in these subset of patients due to various confounding factors like aphasia,depressed sensorium, and motor and sensory deficits which are usually associated with primary disease itself.Data on incidence of delirium in these subset of patients in Indian subcontinent is sparse.Therefore, we intend to study the incidence of delirium in acute stroke patients admitted to ICU using two validated scoring systems:Richmond Agitation Sedation Scale (RASS), and the CAM-ICU and its impact on patient outcomes.

 
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