| 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
|
|
|
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
|
|
|
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. |