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CTRI Number  CTRI/2017/08/009209 [Registered on: 01/08/2017] Trial Registered Prospectively
Last Modified On: 01/08/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   effect of increase in BP on brain energy metabolism 
Scientific Title of Study   Assessment of effect of Cerebral Perfusion Pressure augmentation in Severe Head Injuries by Monitoring of Regional Energy Metabolism by cerebral microdialysis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashish Bindra 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No. 316, Department of Neuroanesthesiology and Critical Care, Administrative block, Jai Prakash Narain Apex Trauma Centre, All India Institute of Medical Sciences.

South
DELHI
110029
India 
Phone  986838607  
Fax    
Email  dr_ashi2208@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Bindra 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  ROOM NO. 316, Department of Neuroanaesthesiology and Critical Care, Jai Prakash Narain, Apex Trauma Centre, All India Institute of Medical Sciences
Room No. 316, Administrative block, Jai Prakash Narain Apex Trauma Centre, All India Institute of Medical Sciences.
South
DELHI
110029
India 
Phone  986838607  
Fax    
Email  dr_ashi2208@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ashish Bindra 
Designation  ASSISTANT PROFESSOR 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  ROOM NO. 316, Department of Neuroanaesthesiology and Critical Care, Jai Prakash Narain Apex Trauma Centre, All India Institute of Medical Sciences
Room No. 316, Department of Neurianesthesiology and Critical Care Administrative block, Jai Prakash Narain Apex Trauma Centre, All India Institute of Medical Sciences.
South
DELHI
110029
India 
Phone  986838607  
Fax    
Email  dr_ashi2208@yahoo.com  
 
Source of Monetary or Material Support  
Research Section, Project Code A-472, 1st Floor, JLN Auditorium INTRAMURAL FUNDING, All India Institute of Medical Sciences, New Delhi Phone No. 011-26594245 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Research Section, 1st Floor, JLN Auditorium, All India Institute of Medical Sciences, New Delhi. 
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 Ashish Bindra  Jai Prakash Narain Apex Trauma Centre, AIIMS  Room No. 316, Department of Neuroanaesthesiology and Critical Care, JPNA Trauma Centre, AIIMS, New Delhi
South
DELHI 		 98698398607

dr_ashi2208@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Head Injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Increase in mean arterial pressure by 10%  In patients where LPR is high, mean arterial pressure will be augmented using Noradrenaline infusion Inj Noradrenaline 2-20mcg/min IV, till LPR is normal or for 12 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  20 adult patients of either gender, undergoing decompressive craniotomy following traumatic brain injury will be enrolled, over a period of 6 months 
 
ExclusionCriteria 
Details  patients where microdialysis catheter cannot be placed or those with Glasgow coma score of 3 on admission, age less than 18 years, pregnant females and associated severe polytrauma. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
• To see the effect of CPP augmentation on ischemia biomarkers (LP Ratio) and intracranial pressure  Every one hour till 48 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
• To see the correlation between CPP, ICP, ischemia biomarkers on outcome in these patients.
• To see the time interval between increase in ischemia biomarkers and clinical worsening (neurological status, rise in ICP)
• To study the incidence of ischemia as measured by cerebral micodialysis (Lactate, pyruvate and LP ratio) in severe traumatic brain injury following decompressive craniectomy.  		 Every hour till 48 hours 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/08/2017 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
It is prospective, single arm interventional study, to be done in patients with severe head injury undergoing decompressive craniectomy. Cerebral microdialysis is a technique in which biomarkers of ischemia can be detected well before the clinical signs of neurological injury are detected. In this way cerebral microdialysis is proposed to offer a window period to treat ischemia well before its overt manifestation. We plan to conduct this study in which microdialysis catheter will be inserted in brain parenchyma at the time of surgery. This microdialysis cathere will help to analyse brain biochemistry in postoperative period. In patients developing ischemia (as seen by elevation in brain biomarkers of cerebral microdialysis)  following operation, the cerebarl perfusion pressure will be increased by 20% with the help of noradrenaline infusion. Augmentation in cerebral perfusion pressure should improve brain ischemia and thus normalise the brain biochemical markers of ischemia as studied by cerebral microdialysis.
 
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