| 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
|
|
|
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
|
|
|
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
|
|
|
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. |