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CTRI Number  CTRI/2025/03/083644 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A comparison on a scoring system obtained with transesophageal echocardiography with central venosus pressure and pulse pressure variation during cardiac valve surgery to guide fluid management : an interventional study 
Scientific Title of Study   A comparison of intraoperative VExUS score with central venous pressure and pulse pressure variation in guiding fluid management in patients undergoing valvular cardiac surgery: an interventional 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  SHAREK 
Designation  SENIOR RESIDENT 
Affiliation  AIIMS Raipur 
Address  AIIMS RAIPUR Department of Anaesthesia, 4th Floor B block, OT 1,2. G.E. Road, opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  9567645694  
Fax    
Email  sharek.mallu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Subrata Kumar Singha 
Designation  Head of the Department of Anaesthesia 
Affiliation  AIIMS Raipur 
Address  AIIMS RAIPUR Department of Anaesthesia, 4th Floor B block, OT 1,2. G.E. Road, opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  8518881767  
Fax    
Email  subratsing@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SHAREK 
Designation  SENIOR RESIDENT 
Affiliation  AIIMS Raipur 
Address  AIIMS RAIPUR Department of Anaesthesia, 4th Floor B block, OT 1,2. G.E. Road, opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  9567645694  
Fax    
Email  sharek.mallu@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur 
 
Primary Sponsor  
Name  Sharek  
Address  AIIMS Raipur, G.E. Road, opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh  
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 Sharek  AIIMS Raipur, 4th Floor, B Block, OT number 1,2  AIIMS Raipur, G.E Road, opposite Gurudwara, Tatibandh, Raipur, Chhattisgarh
Raipur
CHHATTISGARH 
9567645694

sharek.mallu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I080||Rheumatic disorders of both mitraland aortic valves,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Administring fluids intraoperatively based on VExUS score  VExUS score assessed intraoperatively will be used to decide up on fluid administration. Lower VExUS scores allow more fluid administration and higher scores, fluid is withheld. 
Comparator Agent  Comparing VExUS score with Pulse pressure variation and central venous pressure.  Comparing VExUS score obtained by Transesophageal echocardiography with older fluid assessment modalities like pulse pressure variation and central venous pressure  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients belonging to both genders of age group 18 to 65 years,
NYHA grade one and two,
Posted for elective single valve replacement i.e. Aortic or Mitral Valve replacement,
Signed informed consent given by the patient
 
 
ExclusionCriteria 
Details  • Patient refusal
• Double valve replacement patients
• Redo surgery
• Diagnosed heart failure patients.
• Patients contraindicated for esophageal echocardiography
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine that VExUS score is superior to pulse pressure variation and central venous pressure in determining fluid status intraoperatively.  The outcome will be assessed on the day of surgery in one day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in fluid management & fluid homeostasis.
2. Prevents multi organ fluid congestion.
3. Improved surgical outcome.
4. Reduces morbidity & mortality.
 
All outcomes will be assessed on the day of surgery, in a single day 
 
Target Sample Size   Total Sample Size="41"
Sample Size from India="41" 
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 1 
Date of First Enrollment (India)   07/04/2025 
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 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  

Intraoperative fluid administration is a crucial element of anaesthesia management. While fluids may have beneficial effect, excessive fluid administration can lead to fluid buildup, which has been linked to negative side effects and subpar clinical results. Longer mechanical ventilation, renal failure, and possibly death are linked to fluid overload.[1,2]. Fluid buildup is a significant risk factor for extending mechanical ventilation, according to a 2020 prospective observational analysis by Da Silva SC et al. that included 496 patients undergoing coronary artery bypass graft (CABG).[3]Acute kidney injury (AKI) and positive fluid balance are correlated in patients undergoing general cardiac surgery; patients with zero fluid balance have the lowest risk of AKI. [4] In a multicenter randomized controlled research involving 171 patients, a statistically significant association was discovered between the use of diuretics and early ventilator weaning.[5] Therefore, especially in heart surgery, having zero or negative fluid balance before to extubation is essential.

Fast-track treatment in cardiac surgery refers to the use of anesthetic medicines that allow patients having cardiac surgery to discontinue mechanical ventilation quickly in the postoperative period.[6,7]According to current statistics, the earliest and safest time for fast tracking in cardiac surgery patients was within three hours after surgery.[8]Studies suggest that fast-track cardiac surgical management leads to better patient outcomes, shorter hospitalizations in the intensive care unit (ICU), shorter hospital stays, and lower health-care costs. Furthermore, several studies have found that the fast tracking does not increase the incidence of postoperative complications, death, or reintubation rates.

The Venous Excess Ultrasound Score (VExUS), a minimally invasive indicator of venous congestion, has gained popularity since its launch in 2020. By analyzing the inferior vena cava and hepatic and portal vein Doppler flow indices, the VExUS score assesses systemic congestion. This modality has a number of expanding and promising uses. 

However, there are no reports of complete VExUS evaluations using transesophageal echocardiography (TEE), a technique frequently employed in cardiac surgery patients. 

Consequently, the current study will look into how the VExUS score affects patients having single valve replacement surgeries in terms of fluid management.

 
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