Using the Superior Vena Cava Collapsibility Index to Predict Fluid Needs During High-risk Surgery
Predicting Fluid REsponsiveness Using Superior Vena Cava Collapsibility IndEx duriNg High-risk Non-Cardiac surgEry (PRESCIENCE)
This study is testing if a new method for measuring blood vessel changes can help doctors better decide how much fluid patients need during high-risk surgeries to avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uniwersytecki Szpital Kliniczny w Opolu Academic / other |
| Locations | 1 site (Opole) |
| Trial ID | NCT06188039 on ClinicalTrials.gov |
What this trial studies
This prospective study aims to validate the superior vena cava collapsibility index (SVC-CI) as a reliable predictor of fluid responsiveness in patients undergoing high-risk non-cardiac surgeries, such as laparotomy and open aortic surgery. The study will assess the SVC-CI using transesophageal echocardiography and will include three arms to evaluate its effectiveness under various surgical conditions, including elevated PEEP levels and aortic cross clamping. By improving the accuracy of fluid management during surgery, the study seeks to reduce postoperative complications and mortality rates.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old undergoing high-risk non-cardiac surgeries, specifically open aortic surgery or laparotomy.
Not a fit: Patients with conditions that increase the risk of harm from fluid overload, such as end-stage renal disease or decompensated heart failure, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective fluid management during high-risk surgeries, potentially decreasing postoperative complications and mortality.
How similar studies have performed: While the use of SVC-CI is a novel approach in this context, similar studies have shown promise in improving fluid management during surgeries.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Opole
- Opole University Hospital — Opole, Poland (Recruiting)
Study contacts
- Study coordinator: Tomasz Królicki, MD, PhD
- Email: tomasz.krolicki@usk.opole.pl
- Phone: 0774520302
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.