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CTRI Number  CTRI/2024/11/076762 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Preventive
Screening 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Ultrasonographic assessment to maintain optimal cerebral perfusion and titrate norepinephrine in patients with septic shock  
Scientific Title of Study   Use of trans cranial doppler to titrate norepinephrine for optimal cerebral perfusion in septic shock 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JASMINE KAUR KOCHHAR 
Designation  Senior Resident 
Affiliation  Dayanand Medical College and Hospital, Ludhiana  
Address  Department of Critical Care Medicine Dayanand Medical College and Hospital Ludhiana Department of Critical Care Medicine Dayanand Medical College and Hospital, Ludhiana Ludhiana PUNJAB

Ludhiana
PUNJAB
141001
India 
Phone  9478804850  
Fax    
Email  jasminekochhar123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P L Gautam  
Designation  Professor and Head 
Affiliation  Dayanand Medical College and Hospital, Ludhiana 
Address  Department of Critical Care Medicine Dayanand Medical College and Hospital Ludhiana Department of Critical Care Medicine Dayanand Medical College and Hospital, Ludhiana Ludhiana PUNJAB

Ludhiana
PUNJAB
141001
India 
Phone  9814176565  
Fax    
Email  parshotamg@yahoo.com  
 
Details of Contact Person
Public Query  
Name  JASMINE KAUR KOCHHAR 
Designation  Senior Resident 
Affiliation  Dayanand Medical College and Hospital, Ludhiana 
Address  Department of Critical Care Medicine Dayanand Medical College and Hospital Ludhiana Department of Critical Care Medicine Dayanand Medical College and Hospital, Ludhiana Ludhiana PUNJAB

Ludhiana
PUNJAB
141001
India 
Phone  9478804850  
Fax    
Email  jasminekochhar123@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital,civil lines,Tagore nagar ,LUDHIANHA,PUNJAB 141001 INDIA 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Department of Critical Care, Medicine, Dayanand Medical College,Civil lines,Tagore nagar,Ludhiana,Punjab 141001 INDIA 
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 JASMINE KAUR KOCHHAR  Dayanand Medical College and Hospital, Ludhiana  Department of Critical Care Medicine, 4th Floor, ICU block Ludhiana PUNJAB
Ludhiana
PUNJAB 		 9478804850

jasminekochhar123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B998||Other infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Norepinephrine  Titration of Norepinephrine dose based on pulsatility index on Transcranial Doppler 
Comparator Agent  Pulsatility index on Transcranial Doppler  Titration of Norepinephrine based on Mean Arterial Pressure without Pulsatility index on Transcranial Doppler 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patient admitted to Intensive Care Units with early septic shock defined as within 6 hours of start of norepinephrine infusion 
 
ExclusionCriteria 
Details  Age less than eighteen years
Negative consent for participation in study
Known cerebrovascular lesions and events like ischemic or hemorrhagic stroke
History of head injury or other causes of increased ICP
Known cerebral infection
Known severe Carotid artery stenosis
Other causes leading to encephalopathy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To titrate norepinephrine infusion using Trans cranial Doppler variable, pulsatility index ,to maintain optimal cerebral perfusion in septic shock and to assess the neurological outcome when TCD is used to titrate the norepinephrine infusion.  Day 0, Day 1, Day 3 and after inotropes are stopped 
 
Secondary Outcome  
Outcome  TimePoints 
● Assessment of change in neurological status in patients with septic shock when PI is used to titrate norepinephrine dose.
● To assess the impact of TCD derived titration of nor epinephrine on length of ICU stay, ventilator free days, & outcome.
 		 Day 0, Day 1, Day 3 & when inotropes are stopped 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/12/2024 
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 Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  data can be available on request on mail to jasminekochhar123@gmail.com

  6. For how long will this data be available start date provided 13-12-2026 and end date provided 30-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary   Cerebral perfusion is altered during early sepsis. Transcranial doppler ultrasound (TCD) reflects cerebral blood flow velocities which may be considered a surrogate for cerebral perfusion. Cerebral perfusion can be assessed by transcranial doppler ultrasound (TCD). Norepinephrine, while increasing mean arterial pressure (MAP), has been shown to restore cerebral blood flow (CBF), which can be assessed using TCD.TCD being a non invasive tool proves as a  surrogate for cerebral perfusion pressure and thus guide the resuscitation and titration of norepinephrine dose for adequate and CPP and assess the neurological outcomes due to poor cerebral perfusion.

  
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