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CTRI Number  CTRI/2024/10/075067 [Registered on: 10/10/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [comparing sonographic indices]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare Aortocaval index and IVC collapsibility index for fluid administration in septic shock patients 
Scientific Title of Study   To compare Aorto-Caval Index versus IVC Collapsibility Index in assessing fluid responsiveness in patients presenting with Septic Shock to Emergency Department – A Pilot Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harikrishnan S 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Emergency Medicine, AIIMS Hostel No 12, Room No 202, All India Institute of Medical Sciences, New Delhi

New Delhi
DELHI
110029
India 
Phone  9495594910  
Fax    
Email  vava.krishnan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash Ranjan Mishra 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Emergency Medicine, Ground Floor, Main block, All India Institute of Medical Sciences, New Delhi


DELHI
110029
India 
Phone  8826118924  
Fax    
Email  ranjan.prakashmishra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harikrishnan S 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Department of Emergency Medicine, AIIMS Hostel No 12, Room No 202, All India Institute of Medical Sciences, New Delhi


DELHI
110029
India 
Phone  9495594910  
Fax    
Email  vava.krishnan@gmail.com  
 
Source of Monetary or Material Support  
Department of Emergency Medicine, All India Institute of Medical Sciences, New Delhi-110029, India. 
 
Primary Sponsor  
Name  Dr Harikrishnan S 
Address  AIIMS Hostel No 12, Room No 202, All India Institute of Medical Sciences, New Delhi-110029, India 
Type of Sponsor  Other [Self] 
 
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 Harikrishnan S  AIIMS, New Delhi  Department of Emergency Medicine, All India Institute of Medical Sciences, New Delhi
New Delhi
DELHI 		 9495594910

vava.krishnan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, All India Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aorto-caval index  Aorto-Caval index is taken as the ratio of maximum diameter of IVC to the maximum diameter of Aorta. 
Comparator Agent  IVC Collapsibility Index  IVC Collapsibility index is defined as the ratio of the difference in IVC diameter during expiration and inspiration to the IVC diameter during expiration expressed as percentage. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients presenting to the Emergency Department in Septic Shock (Systolic BP less than
90mmHg or Shock Index more than 1) as screened using NEWS score more than or equal to 5.
Age greater than or equal to 18 years
Valid consent given by the patient or Legally Accepted Representative (LAR)  
 
ExclusionCriteria 
Details  Patients less than 18 years of age
Patients presenting in Cardiac Arrest.
Patients with ascites, increased intra-abdominal pressure or intra-abdominal pathologies
like space occupying lesions.
Pregnant women
Intubated patients on mechanical ventilation support.  
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare Aorto-Caval Index versus IVC Collapsibility Index in assessing fluid
responsiveness in patients presenting with Septic Shock to Emergency Department. 		 at baseline, 30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effect of Passive Leg Raising (PLR) on Aorto-caval index & Inferior
Vena Cava (IVC) Collapsibility Index.  		 at baseline, 30 minutes 
To check the feasibility of incorporating Aorto-Caval Index in RUSH protocol for
baseline fluid status & dynamic fluid resuscitation.  		 at baseline, 30 minutes 
To compare the difference between Aorto-caval index obtained from subxiphoid &
transhepatic right coronal views. 		 at baseline, 30 minutes 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 2 
Date of First Enrollment (India)   21/10/2024 
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="2"
Months="0"
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 - NO
Brief Summary  
This study is a prospective, randomized controlled, single-centre, trial comparing Aorto-Caval Index versus IVC Collapsibility Index in assessing fluid responsiveness in patients presenting with Septic Shock to Emergency Department. in 100 patients who are presenting to the Emergency Department in Septic Shock that will be conducted in All India Institute of Medical Sciences, New Delhi.
The primary outcome is to compare Aorto-Caval Index versus IVC Collapsibility Index in assessing fluid responsiveness in patients presenting with Septic Shock to Emergency Department.
The secondary outcome is to assess the effect of Passive Leg Raising (PLR) on Aorto-caval index and Inferior Vena Cava (IVC) Collapsibility Index, to check the feasibility of incorporating Aorto-Caval Index in RUSH protocol for baseline fluid status and dynamic fluid resuscitation and to compare the difference between Aorto-caval index obtained from subxiphoid and transhepatic right coronal views.
 
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