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Search / Trial NCT06188039

Superior Vena Cava Collapsibility Index for Predicting Fluid Responsiveness During High-risk Non-cardiac Surgery

Launched by UNIWERSYTECKI SZPITAL KLINICZNY W OPOLU · Jan 2, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

Fluid Responsiveness Non Cardiac Surgery Superior Vena Cava Collapsibility Index Echocardiography

ClinConnect Summary

This clinical trial is looking to see if a specific measurement called the superior vena cava collapsibility index (SVC-CI) can help doctors predict how well patients will respond to fluid during certain high-risk surgeries, such as laparotomy and open aortic surgery. By using a special imaging technique called transesophageal echocardiography, the study aims to gather data on how patients handle fluid during these procedures. The researchers believe that by understanding fluid responsiveness better, they can improve patient care and potentially reduce the risk of serious complications after surgery.

To be eligible for this study, participants must be over 18 years old and provide signed consent. There are three groups in the study: one for patients having open aortic surgery, another for those undergoing laparotomy, and a third specifically for laparotomy patients with a normal heart rhythm. However, individuals with certain health issues, such as severe kidney or heart problems, or those who can't safely undergo the imaging procedure, will not be included. Participants can expect close monitoring during surgery, and their responses to fluid will be carefully recorded to help improve future treatment approaches.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 1. 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
  • 2. 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)

About Uniwersytecki Szpital Kliniczny W Opolu

Uniwersytecki Szpital Kliniczny w Opolu is a leading clinical research institution dedicated to advancing medical knowledge and patient care through innovative clinical trials. With a multidisciplinary team of experienced healthcare professionals, the hospital fosters a collaborative environment that prioritizes patient safety and ethical standards. By engaging in cutting-edge research across various medical fields, the facility aims to contribute to the development of new treatments and therapies, ultimately enhancing health outcomes for diverse populations. Through its commitment to excellence in clinical research, Uniwersytecki Szpital Kliniczny w Opolu plays a pivotal role in the advancement of healthcare practices both locally and globally.

Locations

Opole, , Poland

Patients applied

0 patients applied

Trial Officials

Tomasz Królicki, MD, PhD

Study Chair

Uniwersytecki Szpital Kliniczny w Opolu

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported