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CTRI Number  CTRI/2024/02/062452 [Registered on: 08/02/2024] Trial Registered Prospectively
Last Modified On: 31/01/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare NICOM vs Invasive monitoring method for blood loss in liver donor surgeries 
Scientific Title of Study   The feasibility of non-invasive cardiac output monitoring in living donor right hepatectomy – A prospective 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  Roopa M N 
Designation  Senior Specialist 
Affiliation  Aster CMI hospital 
Address  Department of Anaesthesiology. Aster CMI Hospital, Sahakar Nagar, Bangalore.

Bangalore Rural
KARNATAKA
560092
India 
Phone  9886523983  
Fax    
Email  dr.mnroopa@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Roopa M N 
Designation  Senior Specialist 
Affiliation  Aster CMI hospital 
Address  Department of Anaesthesiology. Aster CMI Hospital, Sahakar Nagar, Bangalore.

Bangalore Rural
KARNATAKA
560092
India 
Phone  9886523983  
Fax    
Email  dr.mnroopa@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Roopa M N 
Designation  Senior Specialist 
Affiliation  Aster CMI hospital 
Address  Department of Anaesthesiology. Aster CMI Hospital, Sahakar Nagar, Bangalore.

Bangalore Rural
KARNATAKA
560092
India 
Phone  9886523983  
Fax    
Email  dr.mnroopa@gmail.com  
 
Source of Monetary or Material Support  
Aster Intramural Research funding. Aster CMI Hospital. Bangalore 560092 
 
Primary Sponsor  
Name  Roopa M N 
Address  Aster CMI Hospital 
Type of Sponsor  Other [Intramural funding] 
 
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 Roopa M N  Operation theatre, 2nd floor  Department of Anaesthesiology. Aster CMI Hospital, Sahakar Nagar, Bangalore.
Bangalore
KARNATAKA 
9886523983

dr.mnroopa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aster - Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Organ transplant - Living donors 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Arterial line, Central line  Fluid administered to target a CVP ≤ 5, PPV 5-10%. Through out the surgery. Intraoperative period. 
Intervention  NICOM device  Fluid administered to target a CVP ≤ 5, PPV 5-10%. Through out the surgery. Intraoperative. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Living donor hepatectomy surgeries 
 
ExclusionCriteria 
Details  Refusal to participate. Left lobe hepatectomy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess fluid administration.  Perioperatively. At the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess blood loss & blood product administration. To assess lactate, kidney function & hemodynamic stability.  Perioperatively. At the end of surgery. 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   15/02/2024 
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)  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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dr.mnroopa@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Living donor liver transplantation (LDLT) is an established treatment modality for end-stage liver disease and it alleviates the shortage of cadaveric donor organs. Donor safety during the perioperative period is a major concern of LDLT. In general, hepatectomy causes a significant blood loss which is among the major causes of post-operative morbidity and mortality. Any strategy to reduce blood loss during hepatectomy is important and various surgical and anaesthetic methods have been reported. Although low central venous pressure technique can still be effective, it may not be advantageous concerning the safety of healthy donors undergoing hepatectomy. Emerging evidence suggests that stroke volume variation, a simple and useful index for fluid responsiveness and preload status in various clinical situations, can be applied as a guide for fluid management to reduce blood loss during living donor hepatectomy. Most hemodynamic monitors used widely now are invasive, which may cause complications and bring discomfort to the patients. NICOM is an application of biological reactor technology, monitoring cardiac output, cardiac index, stroke volume, stroke volume variability and other hemodynamic parameters by analysing electric pulses through the frequency change of chest.

 
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