About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years or older
Undergoing elective or emergent open-heart surgery with the use of Cardiopulmonary Bypass (CPB)
Disqualifiers
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
Trial population
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
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
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
Secondary outcomes
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
Duration of mechanical ventilation
Duration of mechanical ventilation will be defined as the time from postoperative ICU admission to successful extubation.
ICU length of stay
ICU length of stay will be defined as the number of days from ICU admission to ICU discharge.
30-day mortality
Thirty-day mortality will be defined as all-cause death occurring within 30 days after cardiac surgery.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.