| CTRI Number |
CTRI/2024/03/063517 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Can blood flow variations in the brain be used to assess confusional state in heart failure patients admitted to Cardiac Intensive care unit. |
|
Scientific Title of Study
|
Serial transcranial Doppler velocity measurement as a screening tool for delirium in decompensated heart failure patients admitted to Cardiac ICU. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version: 2.0 dated 10/1/2024 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vimal Bhardwaj |
| Designation |
Consultant Intensivist |
| Affiliation |
Narayana Health |
| Address |
Critical Care Unit, 6th floor, Narayana Institute Of Cardiac Sciences, Narayana Health, Bommasandra, Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
9686124830 |
| Fax |
|
| Email |
vmlbhardwaj@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vimal Bhardwaj |
| Designation |
Consultant Intensivist |
| Affiliation |
Narayana Health |
| Address |
Critical Care Unit, 6th floor, Narayana Institute Of Cardiac Sciences, Narayana Health, Bommasandra, Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
9686124830 |
| Fax |
|
| Email |
vmlbhardwaj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimal Bhardwaj |
| Designation |
Consultant Intensivist |
| Affiliation |
Narayana Health |
| Address |
Critical Care Unit, 6th floor, Narayana Institute Of Cardiac Sciences, Narayana Health, Bommasandra, Bengaluru
Bangalore
KARNATAKA
560099
India |
| Phone |
9686124830 |
| Fax |
|
| Email |
vmlbhardwaj@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Narayana Health, 258/A Bommasandra Industrial area, Hosur Road, Bengaluru, 560099 |
|
|
Primary Sponsor
|
| Name |
Dr Vimal Bhardwaj |
| Address |
Critical Care Unit, 6th floor, Narayana Institute Of Cardiac Sciences, Narayana Health, Bengaluru |
| Type of Sponsor |
Other [Self ] |
|
|
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 Vimal Bhardwaj |
Narayana Health |
Critical Care Unit, 6th floor, Narayana Institute Of Cardiac Sciences, Bommasandra, Bengaluru, 560099
Bangalore
KARNATAKA |
9686124830
vmlbhardwaj@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Health Academic Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I509||Heart failure, 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 |
All ICU patients aged more than 18 years admitted with decompensated heart failure with the any one of the following:
1.Not requiring invasive mechanical ventilation
2.Intubated patients with RASS score of more than -3
3.Patients in shock with Vasoactive inotropic score less than 5
|
|
| ExclusionCriteria |
| Details |
1. Patient or the primary caregiver not giving consent.
2. Patients with poor transcranial window
3. Patients with abnormal findings on brain imaging, if available
4. Patients with PaO2 less than 60mm hg on the day of TCD screening.
5. PaCO2 less than 32mm hg or more than 45mm hg on the day of TCD screening.
6. Past history of cognitive disorders
7. Previous or current Stroke/intracranial bleeding
8. Hypothermia with core body temperature less than 34 degree celsius on the day of TCD screening.
9. Hypertension with blood pressure more than 180/110 mm hg during TCD screening.
10. Hypotension with mean arterial pressure less than 60 mm hg during TCD screening.
11. RAAS Score of more than +2 during TCD screening.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To explore if serial transcranial blood flow velocity measurement by a bedside ultrasound Doppler
can be used as a screening tool to predict delirium in decompensated heart failure patients admitted to cardiac ICU. |
Until in ICU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine if abnormal VExUS scores are associated with a higher risk of delirium. |
Until in ICU |
| To determine the relationship between VExUS scoring and TCD measurements. |
Until in ICU |
|
|
Target Sample Size
|
Total Sample Size="327"
Sample Size from India="327"
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)
|
11/03/2024 |
| 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="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 - NO
|
|
Brief Summary
|
Delirium is a serious medical disorder diagnosed in hospitalized patients, especially in ICU. Its incidence in the cardiac ICU is 15-20%. Diagnosis of delirium in the ICU is crucial since it has been associated with increased days on ventilator, prolonged hospitalization with associated increased costs and mortality.
The use of a bedside transcranial Doppler to measure the middle cerebral artery (MCA) blood flow velocities in delirium has been reported. Caplan et al reported that MCA flow velocities measured through a transcranial Doppler could be a potential diagnostic and a monitoring tool for delirium superimposed on dementia.
However, the sample size in these studies were small. Hence, we propose to study the efficacy of TCD measured MCA velocities to predict delirium in decompensated heart failure patients admitted to ICU. We also aim to explore the association of degree of venous congestion (assessed by VExUS) with delirium.
|