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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHanoi Medical University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

135 Participants
are grouped into 2 trial groups
Group A: Overall Cohort
Group B: PiCCO Subgroup

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

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