SurgeryPRESCIENCENCT06188039
Superior Vena Cava Collapsibility Index for Predicting Fluid Responsiveness During High-risk Non-cardiac Surgery
A study testing Superior vena cava collapsibility index and PEEP elevation in people with Surgery and Fluid Responsiveness, run by Uniwersytecki Szpital Kliniczny w Opolu at 1 site in Poland.
Trial 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 patients' response to fluid will be assessed based on transesophageal echocardiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Fluid Responsiveness, Transesophageal Echocardiography
- What is being tested?
- Superior vena cava collapsibility index and PEEP elevation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 3 Jan 2024to 18 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predicting Fluid REsponsiveness Using Superior Vena Cava Collapsibility IndEx duriNg High-risk Non-Cardiac surgEry (PRESCIENCE)
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 patients' response to fluid will be assessed based on transesophageal echocardiography.
The study has three arms, in order to validate SVC-CI under the conditions of laparotomy, aortic cross clamping and high PEEP levels. One of the study arms will be an active comparator arm.
The data obtained from this study may help physicians guide intraoperative fluid therapy in a more efficient manner, in order to decrease perioperative mortality.
Read the 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. Perioperative fluid therapy is a factor which is strongly associated with postoperative outcomes. To avoid both hypovolemia and excessive fluid administration a strategy of goal-directed fluid therapy (GDFT) has been coined. Traditionally in the setting of operating rooms GDFT relied on stroke-volume variation (SVV) measured by hemodynamic monitors, based on uncalibrated pulse contour cardiac output analysis (uAPCO). However in the described cohort of patients uAPCO methods show a significantly increased measurement error, which is mainly attributed to dynamic changes in peripheral vascular tone. Furthermore, frequent occurrence of arhytmias in those patients limits the use of SVV and all other dynamic indices of fluid responsiveness based on those methods. Superior vena cava collapsibility index (SVC-CI) is a parameter which is devoid of the above mentioned limitations. It relies on respiratory variation of superior vena cava during the respiratory cycle and is therefore reliable in patients with irregular heart rhytm and seems independent from changing afterload conditions.
The main purpose of this study is to validate SVC-CI in patients undergoing controlled mechanical ventilation during laparotomies and during open aortic surgery, with focus on elevated PEEP levels and aortic cross-clamping.
- Being tested
- Superior vena cava collapsibility index, PEEP elevation
- Keywords
- Fluid responsiveness, non-cardiac surgery, Superior vena cava collapsibility index, echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superior vena cava collapsibility indexDiagnostic test
Also called SVC-CI, fluid bolus, transesophageal echocardiography
After induction of general anaesthesia following interventions will be performed.
- Insertion of a tranesophageal echocardiography probe
- Measurement of SVC-CI
- Measurement of LVOT-VTI prior to fluid bolus
- Fluid bolus (250ml of crystalloid)
- Measurement of LVOT-VTI after fluid bolus
Several volume trials per patient will be allowed, until safety criteria are met. In such cases further testing will be stopped.
PEEP elevationOther
A transient elevation of positive end-expiratory pressure (PEEP) will be applied, in order to validate SVC-CI in the setting of elevated PEEP.
A PEEP level of 8-10cmH2O will be applied for 1 minute prior to every measurement of SVC-CI. Then the previous PEEP level will be reinstated.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing open aortic surgery with sinus rhythm | Experimental | Arm to validate SVC-CI during open aortic surgery with special focus of predicting FR during aortic cross clamping (n=50). Receives: Diagnostic Test: Superior vena cava collapsibility index |
| Patients undergoing laparotomy and high PEEP | Experimental | Arm designed to validate SVC-CI during laparotomy, ventilated with high PEEP levels (8-10cmH2O). PEEP will be raised transiently during measurements (n=50). Receives: Diagnostic Test: Superior vena cava collapsibility index; Other: PEEP elevation |
| Patients undergoing laparotomy with standard ventilatory settings | Active comparator | Arm designed as an active comparator with standard (protective) ventilatory settings (n=50). Tidal volumes (Vt) will be set for 8ml/kg. Receives: Diagnostic Test: Superior vena cava collapsibility index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid responsiveness
Fluid responsiveness was defined as an increase of 10% or more of cardiac output (CO) following an administered 250ml fluid bolus. Changes in CO will be estimated using changes in left ventricle outflow tract velocity time integral (LVOT-VTI) assessed by transesophageal echocardiography to avoid errors associated with measuring LVOT area, which is necessary to calculate CO.
Measured: Directly after infusing fluid bolus.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start3 Jan 2024
- Primary completion17 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w Opolu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Królicki, MD PhD, Uniwersytecki Szpital Kliniczny w Opolu
- Investigators
- Tomasz Królicki, MD, PhD, Study chair, Uniwersytecki Szpital Kliniczny w Opolu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188039
- Sponsor's protocol ID
- W27/KB/2023_TK
- Acronym
- PRESCIENCE
- Status last verified
- Jan 2024
- First submitted
- 13 Dec 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be shared in open access, however no plan has been designed.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Fluid REsponsiveness Using Superior Vena Cava Collapsibility IndEx duriNg High-risk Non-Cardiac surgEry (PRESCIENCE)
- ClinicalTrials.gov ID
- NCT06188039
- Acronym / sponsor ID
- PRESCIENCE / W27/KB/2023_TK
- Keywords
- Fluid responsiveness, non-cardiac surgery, Superior vena cava collapsibility index, echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Uniwersytecki Szpital Kliniczny w OpoluUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 17 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patients' response to fluid will be assessed based on transesophageal echocardiography.
The study has three arms, in order to validate SVC-CI under the conditions of laparotomy, aortic cross clamping and high PEEP levels. One of the study arms will be an active comparator arm.
The data obtained from this study may help physicians guide intraoperative fluid therapy in a more efficient manner, in order to decrease perioperative mortality.
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. Perioperative fluid therapy is a factor which is strongly associated with postoperative outcomes. To avoid both hypovolemia and excessive fluid administration a strategy of goal-directed fluid therapy (GDFT) has been coined. Traditionally in the setting of operating rooms GDFT relied on stroke-volume variation (SVV) measured by hemodynamic monitors, based on uncalibrated pulse contour cardiac output analysis (uAPCO). However in the described cohort of patients uAPCO methods show a significantly increased measurement error, which is mainly attributed to dynamic changes in peripheral vascular tone. Furthermore, frequent occurrence of arhytmias in those patients limits the use of SVV and all other dynamic indices of fluid responsiveness based on those methods. Superior vena cava collapsibility index (SVC-CI) is a parameter which is devoid of the above mentioned limitations. It relies on respiratory variation of superior vena cava during the respiratory cycle and is therefore reliable in patients with irregular heart rhytm and seems independent from changing afterload conditions.
The main purpose of this study is to validate SVC-CI in patients undergoing controlled mechanical ventilation during laparotomies and during open aortic surgery, with focus on elevated PEEP levels and aortic cross-clamping.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing open aortic surgery with sinus rhythm | Experimental | Diagnostic Test: Superior vena cava collapsibility indexArm to validate SVC-CI during open aortic surgery with special focus of predicting FR during aortic cross clamping (n=50). |
| Patients undergoing laparotomy and high PEEP | Experimental | Diagnostic Test: Superior vena cava collapsibility index, Other: PEEP elevationArm designed to validate SVC-CI during laparotomy, ventilated with high PEEP levels (8-10cmH2O). PEEP will be raised transiently during measurements (n=50). |
| Patients undergoing laparotomy with standard ventilatory settings | Active comparator | Diagnostic Test: Superior vena cava collapsibility indexArm designed as an active comparator with standard (protective) ventilatory settings (n=50). Tidal volumes (Vt) will be set for 8ml/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Patients who are deemed to be at risk of harm due to excessive fluid administration:
- Medical contraindication to the use of transesophageal echocardiography:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superior vena cava collapsibility indexAlso: SVC-CI, fluid bolus, transesophageal echocardiographyAfter induction of general anaesthesia following interventions will be performed. 1. Insertion of a tranesophageal echocardiography probe 2. Measurement of SVC-CI 3. Measurement of LVOT-VTI prior to fluid bolus 4. Fluid bolus (250ml of crystalloid) 5. Measurement of LVOT-VTI after fluid bolus Several volume trials per patient will be allowed, until safety criteria are met. In such cases further testing will be stopped. | Diagnostic test | Patients undergoing laparotomy and high PEEP, Patients undergoing laparotomy with standard ventilatory settings, Patients undergoing open aortic surgery with sinus rhythm |
| PEEP elevationA transient elevation of positive end-expiratory pressure (PEEP) will be applied, in order to validate SVC-CI in the setting of elevated PEEP. A PEEP level of 8-10cmH2O will be applied for 1 minute prior to every measurement of SVC-CI. Then the previous PEEP level will be reinstated. | Other | Patients undergoing laparotomy and high PEEP |
Primary outcome
Fluid responsiveness
Time frame: Directly after infusing fluid bolus.
Fluid responsiveness was defined as an increase of 10% or more of cardiac output (CO) following an administered 250ml fluid bolus. Changes in CO will be estimated using changes in left ventricle outflow tract velocity time integral (LVOT-VTI) assessed by transesophageal echocardiography to avoid errors associated with measuring LVOT area, which is necessary to calculate CO.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No. The data will be shared in open access, however no plan has been designed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tomasz Królicki, MD, PhD study chair
Uniwersytecki Szpital Kliniczny w Opolu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superior vena cava collapsibility index and PEEP elevation in people with Surgery and Fluid Responsiveness, run by Uniwersytecki Szpital Kliniczny w Opolu at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluid responsiveness (time frame: Directly after infusing fluid bolus.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.