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CTRI Number  CTRI/2024/07/070944 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 21/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Transcranial Doppler Derived blood flow velocity in Children With sepsis/septic shock 
Scientific Title of Study   Transcranial Doppler Derived Cerebral Hemodynamic Phenotypes in Children With sepsis: A Single Centre Prospective Cohort 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  AMIT KUMAR 
Designation  DrNB Trainee 
Affiliation  St Johns medical college bangalore 
Address  Department of Pediatric Intensive care PICU B Block, Ground Floor St Johns medical college Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9508502428  
Fax    
Email  amitkumar20mbbs@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Lalitha A V 
Designation  Professor & Head, Dept of PICU 
Affiliation  St Johns medical college bangalore 
Address  Department of Pediatric Intensive care PICU B Block, Ground Floor St Johns medical college Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  09448461673  
Fax    
Email  drlalitha03@gmail.com  
 
Details of Contact Person
Public Query
 
Name  AMIT KUMAR 
Designation  DrNB Trainee 
Affiliation  St Johns medical college bangalore 
Address  Department of Pediatric Intensive care PICU B Block, Ground Floor St Johns medical college Bangalore

Bangalore
KARNATAKA
560034
India 
Phone  9508502428  
Fax    
Email  amitkumar20mbbs@gmail.com  
 
Source of Monetary or Material Support  
St. Johns Medical college Bangalore 
 
Primary Sponsor  
Name  Amit Kumar 
Address  Department of Pediatric Intensive care PICU B Block, Ground Floor St Johns medical college Bangalore Karnataka PIN 560034 INDIA 
Type of Sponsor  Other [Self funded] 
 
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 Amit Kumar  St Johns Medical College Bangalore  Department of Pediatric Intensive care PICU B Block, Ground Floor St Johns medical college Bangalore Kormangala bangalore 560034
Bangalore
KARNATAKA 
9508502428

amitkumar20mbbs@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee St. John’s Medical College, Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NA 
Intervention  NIL  NA 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  All children between 1 yr-18 years of age admitted in Paediatric intensive care unit with a diagnosis of sepsis/septic shock 
 
ExclusionCriteria 
Details  A. Children less than 1 year of age
B. Traumatic brain injury
C. CNS malformation
D. CNS malignancy
E. Children with seizure disorder
F. Cerebral palsy
G. Global developmental delay
H. Sickle cell disease
I. Severe acute malnutrition
J. Congenital heart disease
K. Refusal to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To categorize the cerebral flow velocity phenotypes derived from transcranial doppler in children with sepsis.  TCD measurements will be done at
1. Within 6 hours of PICU admission
2. At 12 hours of PICU admission
3. At 24 hours of PICU admission
4. At 48 hours of PICU admission
 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objective:
1. To study the correlation between TCD derived CBFV phenotypes with
A. Hemodynamic parameters (HR, MAP, Lactates, perfusion index).
B. Electro cardiometry derived cardiac output indices.
C. NIRS derived regional cerebral oxygenation parameters.
2. To study the association between TCD derived CBFV phenotypes with the clinical outcomes
A. Duration of inotrope requirement
B. Duration of mechanical ventilation
C. Duration of PICU/hospital stay.
D. Morbidity – sepsis-associated encephalopathy.
E. Mortality.
 
At the time of discharge from hospital 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   15/08/2024 
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)   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  

We propose to study the different phenotypes of transcranial doppler (TCD) derived cerebral blood flow velocity parameters in Indian children with sepsis or septic shock and its association with the clinical outcome in these children.

Dysregulated, self-sustaining, and uncontrolled intravascular inflammation during sepsis lead to rapidly progressing end organ dysfunction culminating in septic shock and multi organ dysfunction. Research in children revealed loss of hemodynamic coherence, i.e., microcirculatory alterations despite normal systemic haemodynamics. Cerebral microcirculation is gradually compromised during sepsis, with significant reductions in the function of capillaries and blood perfusion in small vessels. To develop efficacious adjunctive therapeutic approaches that improve outcomes in paediatric sepsis, mechanisms of neurological injury must be determined. Transcranial Doppler Ultrasound (TCD) is a portable, non-invasive method to assess the cerebral blood flow velocities (CBFVs) and haemodynamics in the major cerebral vessels. The measurement of CBF velocity (CBFV) with TCD can be considered a surrogate of CBF, if it is assumed that the diameter of the vessel remains constant. Therefore, the changes in CBFV detected by TCD could represent the hemodynamic changes mediated by microcirculation. TCD derived CBFVs and morphologic waveforms are determined by the mean arterial pressure, the tone and patency of the systemic and cerebral vessels, and the intracranial and central venous pressures. Alterations to any of these factors results in distinct changes to measured TCD parameters and waveform morphology. Thus, TCD is used as a point of care tool to determine specific mechanisms of focal or global cerebral dysfunction in several clinical scenarios. The rationale behind doing this study is to look for different patterns in TCD derived cerebral hemodynamic parameters in children with septic shock in PICU.

This study is to be done in children of 1 – 18 years age group being admitted in PICU with sepsis or septic shock. Cerebral blood flow velocities, pulsatility index and resistive index will be recorded using transcranial doppler ultrasound at predetermined intervals. Different phenotypes of TCD derived cerebral blood flow velocities in children with sepsis or septic shock will be evaluated. Its correlation with the hemodynamic parameters and its association with the clinical outcomes in pediatric septic shock will be studied.

 
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