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CTRI Number  CTRI/2025/01/079605 [Registered on: 28/01/2025] Trial Registered Prospectively
Last Modified On: 27/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison between two different techniques of fluid management after major abdominal surgeries 
Scientific Title of Study   Postoperative fluid management after major abdominal surgery: Goal directed therapy versus Ultrasound guided volume assessment 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arpan Chakraborty 
Designation  PGT Anaesthesiology 
Affiliation  Institute of Post Graduation Medical Education and Research,Kolkata 
Address  Department of Anaesthesiology IPGME&R and SSKM Hospital 244 AJC Bose Road Kolkata 700020

Kolkata
WEST BENGAL
700020
India 
Phone  8293565067  
Fax    
Email  arpanchakraborty0363@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tapas Ghose  
Designation  Professor, Department of GI Anaesthesiology 
Affiliation  Institute of Post Graduation Medical Education and Research,Kolkata 
Address  Department of GI Anaesthesiology IPGME&R and SSKM Hospital 244 AJC Bose Road Kolkata 700020

Kolkata
WEST BENGAL
700020
India 
Phone  9903745071  
Fax    
Email  g.tapas@gmail.com  
 
Details of Contact Person
Public Query  
Name  Arpan Chakraborty 
Designation  PGT Anaesthesiology 
Affiliation  Institute of Post Graduation Medical Education and Research,Kolkata 
Address  Department of Anaesthesiology IPGME&R and SSKM HOSPITAL 244 AJC Bose Road Kolkata 700020

Kolkata
WEST BENGAL
700020
India 
Phone  8293565067  
Fax    
Email  arpanchakraborty0363@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology IPGME&R and SSKM Hospital 244 AJC Bose Road Kolkata 700020 
 
Primary Sponsor  
Name  Institute of Post Graduation Medical Education and Research 
Address  244 AJC Bose Road Kolkata 700020 
Type of Sponsor  Government medical college 
 
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 Arpan Chakraborty  Institute of Post Graduation Medical Education and Research Kolkata  ITU and ICU, Main Block and SDLD, Department of Anaesthesiology IPGME&R and SSKM HOSPITAL 244 AJC Bose Road Kolkata 700020
Kolkata
WEST BENGAL 		 08293565067

arpanchakraborty0363@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Institute of Post Graduation Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human volunteers who are scheduled for elective major abdominal surgery  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Goal directed therapy  patients will be monitored postoperatively using established goal directed therapy monitoring such as CVP, MAP, urine output and regular hemoglobin levels and alteration in fluid therapy will be done accordingly 
Intervention  Ultrasound guided volume assessment comparator agent here is 2D ultrasound  Post operative monitoring of fluid status of patients using point of care ultrasound to assess venous congestion in IVC, portal vein and hepatic vein using VExUS score and aleration in fluid therapy will be done accordingly 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged between 18 to 60 years, all genders, ASA physical status I and II with no associated comorbidities, having no surgical complications within the study period and no sepsis or cardiogenic shock 
 
ExclusionCriteria 
Details  Patients refuse to give consent, patients having known cardiac and respiratory disorders, contraindications or inability to initiate indwelling catheters, patients with major intra operative hemodynamic or cardiac events, patients requiring elective or emergency post operative ventilation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Point of Care Ultrasound and VExUS scoring will be a more sensitive tool to detect fluid responsiveness and early overload in postsurgical patients  72 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of hypoperfusion or fluid overload events   72 hours postoperatively 
Requirement of vasopressors and diuretics to achieve perfusion goals  72 hours postoperatively 
Incidence of organ dysfunction such as lung congestion, AKI, ileus and altered liver function all attributed to perfusion pressure mismatch  72 hours postoperatively 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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 4 
Date of First Enrollment (India)   08/02/2025 
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="1"
Days="1" 
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   Postoperative fluid management remains a cornerstone in the management of patients undergoing major abdominal surgery and their uneventful outcome.In this study we will manage the fluid status of the patients postoperatively using goal directed therapy and by ultrasound guided volume assessment and VExUS scoring.We expect that,patients with postoperative fluid management guided by the VExUS scoring will have a more optimized fluid support and are expected to have less morbidity, earlier return of gut function, early mobilization and enteral nutrition, lower incidence of systemic volume overload such as pulmonary congestion and respiratory impairment and improved end organ perfusion. 
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