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CTRI Number  CTRI/2025/08/093621 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of efficacy of Eadyn in predicting rise in blood pressure using simple leg raise in septic shock patient  
Scientific Title of Study   Assessment of pressure responsiveness with Eadyn using passive leg raise in adult patient with sepsis - A Prospective Observational 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  Ramya R 
Designation  Senior Resident  
Affiliation  JIPMER 
Address  Department of Anesthesia and critical care, Second floor, Institute block JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  8825919469  
Fax    
Email  ramyacrc96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  KANDASWAMY N 
Designation  Assistant professor 
Affiliation  JIPMER 
Address  Department of Anaesthesiology and Critical care JIPMER PONDICHERRY

Pondicherry
PONDICHERRY
605006
India 
Phone  9952082858  
Fax    
Email  kandaraghav@gmail.com  
 
Details of Contact Person
Public Query  
Name  KANDASWAMY N 
Designation  Assistant professor 
Affiliation  JIPMER 
Address  Department of Anaesthesiology and Critical care JIPMER PONDICHERRY

Pondicherry
PONDICHERRY
605006
India 
Phone  9952082858  
Fax    
Email  kandaraghav@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Intramural Grant Jipmer Administration block Gorimedu Pondicherry 605006 India  
 
Primary Sponsor  
Name  JIPMER  
Address  JIPMER Gorimedu Pondicherry 605006 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 
Ramya  JIPMER  Critical care unit, Ward 21, First floor,Institute block,Gorimedu,Pondicherry . 605006 India
Pondicherry
PONDICHERRY 		 8825919469

ramyacrc96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, JIPMER  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, (2) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adults with preserved spontaneous respiratory efforts aged between 18 to 65 years with sepsis requiring vasopressor therapy to maintain MAP of more than or equal 65 mmHg after initial resuscitation or capillary refill time more than 3 seconds or lactate levels more than 2mmol per litre or urine output less than 0.5ml per kg per hr for at least 2hours.
Sequential organ failure assessment score more than 2.
Patients with arterial catheter and central venous line in situ.  
 
ExclusionCriteria 
Details  Pregnancy
Patients with
Arrhythmias, increased intracranial hypertension, head trauma, pain or agitation
Right heart failure, defined here as evidence of abnormal RV structure or function with clinical signs of right heart failure, including edema in both legs, hepatomegaly
With suspected increased intra-abdominal pressure
Ongoing neuromuscular blockade
Vasoactive Inotropic Score(VIS) 20
With peripheral vascular disease
Burns involving extremities. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the ability of Eadyn-guided dynamic assessment in predicting pressure responsiveness with passive leg raise among critically ill adults with sepsis.   on admission to critical care unit 
 
Secondary Outcome  
Outcome  TimePoints 
To correlate the Eadyn derived from cardiac output monitor alone and the Eadyn derived with echocardiography and cardiac output monitor in responders and non-responders.
 		 on admission to critical care unit 
To compare velocity time integral (VTI) response to PLR and continuous cardiac output monitor stroke volume response between the responders and non-responders  on admission to critical care unit 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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)   17/10/2025 
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  

CO,SBP, DBP, MAP) and HR will be continuously monitored.Baseline stroke volume, Baseline SVR will be assessed. HemoSphere monitor calculates PPV, SVV, and SV every 20 seconds. Eadyn will be calculated from the PPV over SVV ratio. Central venous pressure will be monitored throughout study. Baseline vasoactive inotropic score(VIS ) will be calculated.Passive leg raising as well as the volume expansion will be done. Vasopressors and ventilator settings will not be changed at any time while a patient is being studied. The hemodynamic parameters of SV, PPV, SVV, CI, CO, Eadyn  and SVR will be measured from the continuous cardiac output monitor. There will be a simultaneous SV measurement done with TTE.

Step 1: The patient will be placed in a semi-recumbent position with the head elevated at 45 degrees and the haemodynamic parameters will be noted.

Step 2:  The patient will be positioned supine with the legs straight and elevated at 45 degrees for 90s. The haemodynamic parameters will be noted at 90-120s after giving this position.

Step 3:  Returned to the baseline position.

As a part of standard of care, the patients with change in stroke volume  >15% are categorized as fluid responders, and receive a volume expansion with 250ml of crystalloids over 10 minutes15.

Step 4: Assess the haemodynamic parameters after 2minutes of volume expansion. 

 
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