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Evaluation of the Association Between the VEXUS Score and Hemodynamic Status and the Occurrence of Acute Kidney Injury After Open-Heart Surgery

Evaluation of the Association Between the VEXUS Score and Hemodynamic Status and the Occurrence of Acute Kidney Injury After Open-Heart Surgery

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07805564
Enrollment
135
Registered
2026-09-04
Start date
2026-01-07
Completion date
2027-12-31
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury After Open Heart Surgery, Venous Congestion After Open Heart Surgery

Keywords

Acute Kidney Injury, Venous Congestion, Open heart surgery, PiCCO

Brief summary

Acute kidney injury is a common complication after cardiac surgery with cardiopulmonary bypass and is associated with prolonged intensive care unit stay, increased morbidity, and mortality. Fluid overload and venous congestion are increasingly recognized as important contributors to postoperative organ dysfunction. The VExUS score is a bedside ultrasound tool that assesses systemic venous congestion through evaluation of the inferior vena cava and Doppler flow patterns in the hepatic, portal, and intrarenal veins. Although previous studies have suggested an association between VExUS-assessed venous congestion, AKI, and adverse outcomes, evidence regarding its relationship with advanced hemodynamic parameters remains limited. This prospective observational study will enroll adult patients undergoing cardiac surgery with cardiopulmonary bypass. All patients will undergo postoperative VExUS assessment and will be followed for the development of AKI and other postoperative complications. A predefined subgroup of patients undergoing clinically indicated PiCCO monitoring will additionally be evaluated to determine the association between VExUS score and PiCCO-derived hemodynamic parameters. The findings may support the use of VExUS as a noninvasive bedside tool for assessing venous congestion and identifying patients at increased risk of postoperative organ dysfunction after cardiac surgery.

Detailed description

Acute kidney injury remains a common complication after cardiac surgery with cardiopulmonary bypass and is associated with increased morbidity, mortality, and healthcare utilization. In addition to impaired cardiac output, growing evidence suggests that venous congestion plays an important role in the development of postoperative organ dysfunction. The VExUS score is an ultrasound-based tool that evaluates systemic venous congestion through assessment of the inferior vena cava and Doppler flow patterns in the hepatic, portal, and intrarenal veins. Previous studies have reported associations between venous congestion and adverse renal outcomes; however, data on the relationship between VExUS findings and advanced hemodynamic status in cardiac surgical patients remain limited. This prospective observational study will be conducted in adult patients undergoing cardiac surgery with cardiopulmonary bypass. Postoperative VExUS assessments will be performed at predefined time points to evaluate the degree of venous congestion and its association with clinically relevant outcomes. All enrolled patients will be included in analyses examining the prognostic value of VExUS for postoperative AKI and other complications. In addition, a predefined subgroup of patients undergoing PiCCO monitoring as part of routine clinical care will be evaluated to investigate the relationship between VExUS scores and PiCCO-derived hemodynamic parameters. The study aims to improve understanding of the role of venous congestion in postoperative organ dysfunction and to determine whether VExUS can serve as a practical noninvasive bedside tool for hemodynamic assessment and risk stratification following cardiac surgery.

Interventions

None listed

Sponsors

Hanoi Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients aged 18 years or older * Undergoing elective or emergent open-heart surgery with the use of Cardiopulmonary Bypass (CPB)

Exclusion criteria

* Severe tricuspid regurgitation End-stage chronic kidney disease (estimated glomerular filtration rate below 15 mL per minute per 1.73 square meters) * Preoperative use of an intra-aortic balloon pump (IABP) * Preoperative use of extracorporeal membrane oxygenation (ECMO) or a ventricular assist device (VAD) * Liver cirrhosis, portal hypertension, or portal vein thrombosis * Refusal to participate by the patient or the patient's legally authorized representative

Design outcomes

Primary

MeasureTime frameDescription
The correlation between the severity of systemic venous congestion, quantified by the VExUS grading system, and volumetric hemodynamic parameters (ELWI and GEDI)Within the first 42 postoperative hoursThe severity of systemic venous congestion will be assessed using the Venous Excess Ultrasound (VExUS) grading system, which combines inferior vena cava measurements with Doppler flow assessments of the hepatic, portal, and intrarenal veins. Volumetric hemodynamic status will be evaluated using transpulmonary thermodilution monitoring (PiCCO), including extravascular lung water index (ELWI) and global end-diastolic volume index (GEDI). The association between VExUS grade and these hemodynamic parameters will be analyzed to determine whether increasing venous congestion is associated with greater intravascular volume loading and pulmonary fluid accumulation. VExUS and PiCCO measurements will be performed at predefined postoperative time points (T0, T4, T8, T12, T16, T20, T24, T30, T36, and T42 hours) and analyzed for correlation
The prognostic value of VExUS for postoperative AKIWithin the first 7 postoperative daysPostoperative AKI will be defined and staged according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria based on changes in serum creatinine and urine output. VExUS assessments will be performed on postoperative Days 0, 1, and 2. The ability of VExUS scores and grades to predict the occurrence and severity of AKI will be evaluated according to KDIGO criteria

Secondary

MeasureTime frameDescription
The association between VExUS grades and dynamic indices of fluid responsiveness (SVV and PPV) to characterize the hemodynamic profile of fluid intoleranceWithin the first 42 postoperative hoursSVV and PPV will be measured using PiCCO monitoring at the same time points as VExUS assessment. Correlation analyses will evaluate the association between VExUS grades and dynamic indices of fluid responsiveness to characterize the hemodynamic profile of fluid intolerance. VExUS and PiCCO measurements will be performed at predefined postoperative time points (T0, T4, T8, T12, T16, T20, T24, T30, T36, and T42 hours) and analyzed for correlation
Duration of mechanical ventilationDuring hospitalizationDuration of mechanical ventilation will be defined as the time from postoperative ICU admission to successful extubation.
ICU length of stayDuring hospitalizationICU length of stay will be defined as the number of days from ICU admission to ICU discharge.
30-day mortality30 days after surgeryThirty-day mortality will be defined as all-cause death occurring within 30 days after cardiac surgery.

Countries

Vietnam

Contacts

CONTACTTu Nguyen Huu, Prof
nguyenhuutu@hmu.edu.vn+84904176397
CONTACTMinh Quang Pham, PhD
phamquangminh@hmu.edu.vn+84912424932
STUDY_CHAIRTu Huu Nguyen, Prof

Hanoi Medical University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026