An observational study in Acute Kidney Injury After Open Heart Surgery and Venous Congestion After Open Heart Surgery, sponsored by Hanoi Medical University. Recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Hanoi Medical University · Observational
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.
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's planned enrollment of 135 is below the median of 160 across 814 observational studies indexed under Acute Kidney Injury.
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The study population consists of adult patients undergoing elective or emergency open heart surgery requiring cardiopulmonary bypass at Hanoi Medical University Hospital. Eligible patients will be admitted postoperatively to the Cardiac Surgical Intensive Care Unit and followed for the development of acute kidney injury and other postoperative complications
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients undergoing cardiac surgery with cardiopulmonary bypass who receive postoperative VExUS assessment and follow-up for AKI and other postoperative complications
A subgroup of patients from the overall cohort who undergo PiCCO monitoring based on the clinical judgment of the treating physician. These patients will be included in analyses of the association between VExUS score and PiCCO-derived hemodynamic parameters
The correlation between the severity of systemic venous congestion, quantified by the VExUS grading system, and volumetric hemodynamic parameters (ELWI and GEDI)
The 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
Time frame: Within the first 42 postoperative hours
The prognostic value of VExUS for postoperative AKI
Postoperative 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
Time frame: Within the first 7 postoperative days
The association between VExUS grades and dynamic indices of fluid responsiveness (SVV and PPV) to characterize the hemodynamic profile of fluid intolerance
SVV 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
Time frame: Within the first 42 postoperative hours
Duration of mechanical ventilation
Duration of mechanical ventilation will be defined as the time from postoperative ICU admission to successful extubation.
Time frame: During hospitalization
ICU length of stay
ICU length of stay will be defined as the number of days from ICU admission to ICU discharge.
Time frame: During hospitalization
30-day mortality
Thirty-day mortality will be defined as all-cause death occurring within 30 days after cardiac surgery.
Time frame: 30 days after surgery
Plan to share: No — Prohibited from laws (and/or rules, regulations, contracts); Need a consensus from colleagues
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Hanoi Medical University