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CTRI Number  CTRI/2024/11/077062 [Registered on: 19/11/2024] Trial Registered Prospectively
Last Modified On: 15/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   to compare heart blood flow measurement between two devices in liver transplant recipient  
Scientific Title of Study   To investigate the correlation between cardiac output measurements obtained using the esCCO system on the Nihon Kohden BSM9101 bedside monitor and Flotrac system 
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 Ekta Ranjan 
Designation  DrNB Resident 
Affiliation  Medanta, The Medicity, Gurgaon 
Address  Medanta Institute of Critical Care and Anaesthesia, ICU 9, ICU 10, ICU 11, ICU 12, 2nd Floor, Medanta The Medicity, Sector 38, Gurgaon, Haryana Gurgaon HARYANA 122001 India

Gurgaon
HARYANA
122001
India 
Phone  9711991196  
Fax    
Email  drranjanekta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ekta Ranjan 
Designation  DrNB Resident 
Affiliation  Medanta, The Medicity, Gurgaon 
Address  Medanta Institute of Critical Care and Anaesthesia, ICU 9, ICU 10, ICU 11, ICU 12, 2nd Floor, Medanta The Medicity, Sector 38, Gurgaon, Haryana Gurgaon HARYANA 122001 India

Gurgaon
HARYANA
122001
India 
Phone  9711991196  
Fax    
Email  drranjanekta@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Govil 
Designation  Vice Chairman 
Affiliation  Medanta The Medicity Gurgaon 
Address  Institute of Critical Care and Anesthesiology Medanta The Medicity Sector 38 Gurgaon Haryana 122001

Gurgaon
HARYANA
122001
India 
Phone  9818056688  
Fax    
Email  drdeepak_govil@yahoo.co.in  
 
Source of Monetary or Material Support  
Institute of critical care and anesthesiology Medanta the medicity sector 38 Gurgaon Haryana 122001 India 
 
Primary Sponsor  
Name  Dr Ekta Ranjan 
Address  Institute of Critical Care and Anaesthesiology Medanta The Medicity Gurgaon 122001  
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 Ekta Ranjan  Medanta the Medicity  ICU 9 ICU 10 ICU 11 ICU 12 Institute of critical care and Anesthesia Medanta the medicity Sector 38 Gurgaon Haryana 122001 Gurgaon HARYANA
Gurgaon
HARYANA 		 9711991196

drranjanekta@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee (MIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K769||Liver disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  esCCO device BSM9101 from Nihon Kohden Co., Ltd  The esCCO system by Nihon Kohden is a non-invasive monitoring technology used to estimate cardiac output. It operates by analyzing the electrical impedance of the thorax, providing real-time data on heart function. This system is designed for ease of use in clinical settings, allowing healthcare providers to monitor patients effectively without the need for invasive procedures. 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1 Age above 18 years
2 Post liver transplant patients with FloTrac monitor
3 Hemodynamic instability defined as MAP less than 65 mmHg or maintaining MAP greater than 65 mmHg with vasopressors
 
 
ExclusionCriteria 
Details  1 Inability to perform PLR due to conditions such as raised intracranial pressure or intra abdominal hypertension
2 Cardiac arrhythmias during measurement
3 Aortic valvular abnormalities or use of intra-aortic balloon pumps or pacemakers 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To evaluate the correlation between cardiac output measurements derived from esCCO using pulse wave transit time and Flotrac using pulse contour analysis in post liver transplant recipients
 		 at baseline which is after three minutes of esCCO calibration
 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the changes in cardiac output measured by both systems during passive leg raising test  at one minute after PLR
at one minute after reversal of PLR
 
 
Target Sample Size   Total Sample Size="85"
Sample Size from India="85" 
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)   28/11/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Our study is to compare cardiac output measurement using esCCO by pulse wave transit time and flotrac by pulse contour analysis during PLR on post lover transplant recipients. Study aim to find the correlation between the cardiac measurement derived from esCCO and flotrac. It also compares the variation in cardiac output measurement obtained using both systems during PLR in hemodynamically unstable post liver transplant patients. 
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