Status:
COMPLETED
Superior Vena Cava Collapsibility Index for Predicting Fluid Responsiveness During High-risk Non-cardiac Surgery
Lead Sponsor:
Uniwersytecki Szpital Kliniczny w Opolu
Conditions:
Surgery
Fluid Responsiveness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this prospective study is to validate the superior vena cava collapsibility index (SVC-CI) as a predictor of fluid responsiveness during laparotomy and open aortic surgery. The SVC-CI and ...
Detailed Description
Patients undergoing high-risk non-cardiac surgery, including acute laparotomies and open aortic surgery, are at high risk of postoperative complications and adverse cardiovascular events. Perioperativ...
Eligibility Criteria
Inclusion
- Signed ICF (informed consent form)
- Age \> 18 years old Eligibility criteria for each arm (additionally to mandatory criteria)
- Arm 1 - Patients undergoing open aortic surgery
- Arm 2 - Patients undergoing laparotomy
- Arm 3 - Patients undergoing laparotomy with sinus rhytm
Exclusion
- Patients who are deemed to be at risk of harm due to excessive fluid administration:
- End-stage renal disease (eGFR \<15ml/kg/min)
- Decompensated heart failure
- Respiratory failure prior to surgery
- Other cases where the risk of harm from fluid overload is assessed to be significant by the investigator
- Medical contraindication to the use of transesophageal echocardiography:
- Active ulcerative gastritis or bleeding from upper gastrointestinal tract
- Past history of esophageal or gastric surgery
- Esophageal varices or other esophageal disease (stricture, Barret's disease, perforation in the past, achalasia)
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06188039
Start Date
January 3 2024
End Date
November 18 2025
Last Update
January 6 2026
Active Locations (1)
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1
Opole University Hospital
Opole, Poland, 45-401