Acute Kidney Injury After Open Heart SurgeryNCT07805564
Evaluation of the Association Between the VEXUS Score and Hemodynamic Status and the Occurrence of Acute Kidney Injury After Open-Heart Surgery
An observational study of Acute Kidney Injury After Open Heart Surgery and Venous Congestion After Open Heart Surgery, run by Hanoi Medical University at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury After Open Heart Surgery, Venous Congestion After Open Heart Surgery
- How many people
- 135 participants
- Where
- 1 siteVietnam
- Study dates
- 7 Jan 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study 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
Who may be able to join
- Adult patients aged 18 years or older
- Undergoing elective or emergent open-heart surgery with the use of Cardiopulmonary Bypass (CPB)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
Hanoi Medical University Hospital
Hanoi, Hanoi, 10000
Hieu Lan Nguyen, PhD, +84903439809, nguyenlanhieu@hmu.edu.vn
Phuong Hoang Vu, PhD, +84912300978, vuhoangphuong@hmu.edu.vn
About this study
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.
Read the 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.
- Keywords
- Acute Kidney Injury, Venous Congestion, Open heart surgery, PiCCO
- Medical subject headings
- Acute Kidney Injury, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Overall Cohort | Adult patients undergoing cardiac surgery with cardiopulmonary bypass who receive postoperative VExUS assessment and follow-up for AKI and other postoperative complications | |
| PiCCO Subgroup | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Within the first 7 postoperative days
Secondary outcomes (4)
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
Measured: 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.
Measured: During hospitalization
ICU length of stay
ICU length of stay will be defined as the number of days from ICU admission to ICU discharge.
Measured: During hospitalization
30-day mortality
Thirty-day mortality will be defined as all-cause death occurring within 30 days after cardiac surgery.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start7 Jan 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury After Open Heart 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanoi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luu Xuan Vo, Hanoi Medical University
- Investigators
- Tu Huu Nguyen, Prof, Study chair, Hanoi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805564
- Sponsor's protocol ID
- HMUIRB2363
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prohibited from laws (and/or rules, regulations, contracts); Need a consensus from colleagues
Publications
Rola P, Haycock K, Spiegel R, Beaubien-Souligny W, Denault A. VExUS: common misconceptions, clinical use and future directions. Ultrasound J. 2024 Nov 26;16(1):49. doi: 10.1186/s13089-024-00395-0.
PubMed 39589643Carsetti A, Antolini R, Domizi R, Damiani E, Adrario E, Donati A. Relationship between high VExUS score and echocardiographic parameters: a systematic review and meta-analysis. J Anesth Analg Crit Care. 2026 Jan 28;6(1):34. doi: 10.1186/s44158-026-00347-1.
PubMed 41606663Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w.
PubMed 32270297Longino A, Martin K, Leyba K, Siegel G, Gill E, Douglas IS, Burke J. Correlation between the VExUS score and right atrial pressure: a pilot prospective observational study. Crit Care. 2023 May 26;27(1):205. doi: 10.1186/s13054-023-04471-0.
PubMed 37237315
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between the VEXUS Score and Hemodynamic Status and the Occurrence of Acute Kidney Injury After Open-Heart Surgery
- ClinicalTrials.gov ID
- NCT07805564
- Acronym / sponsor ID
- HMUIRB2363
- Keywords
- Acute Kidney Injury, Venous Congestion, Open heart surgery, PiCCO
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Hanoi Medical UniversityUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Sep 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overall Cohort | – | –Adult patients undergoing cardiac surgery with cardiopulmonary bypass who receive postoperative VExUS assessment and follow-up for AKI and other postoperative complications |
| PiCCO Subgroup | – | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (2 listed)
- Adult patients aged 18 years or older
- Undergoing elective or emergent open-heart surgery with the use of Cardiopulmonary Bypass (CPB)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation between the severity of systemic venous congestion, quantified by the VExUS grading system, and volumetric hemodynamic parameters (ELWI and GEDI)
Time frame: Within the first 42 postoperative hours
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
Time frame: Within the first 7 postoperative days
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
4 secondary outcomes
The association between VExUS grades and dynamic indices of fluid responsiveness (SVV and PPV) to characterize the hemodynamic profile of fluid intolerance
Time frame: Within the first 42 postoperative hours
Duration of mechanical ventilation
Time frame: During hospitalization
ICU length of stay
Time frame: During hospitalization
30-day mortality
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Results publication: PubMed 39589643Rola P, Haycock K, Spiegel R, Beaubien-Souligny W, Denault A. VExUS: common misconceptions, clinical use and future directions. Ultrasound J. 2024 Nov 26;16(1):49. doi: 10.1186/s13089-024-00395-0.
- Results publication: PubMed 41606663Carsetti A, Antolini R, Domizi R, Damiani E, Adrario E, Donati A. Relationship between high VExUS score and echocardiographic parameters: a systematic review and meta-analysis. J Anesth Analg Crit Care. 2026 Jan 28;6(1):34. doi: 10.1186/s44158-026-00347-1.
- Results publication: PubMed 32270297Beaubien-Souligny W, Rola P, Haycock K, Bouchard J, Lamarche Y, Spiegel R, Denault AY. Quantifying systemic congestion with Point-Of-Care ultrasound: development of the venous excess ultrasound grading system. Ultrasound J. 2020 Apr 9;12(1):16. doi: 10.1186/s13089-020-00163-w.
- Results publication: PubMed 37237315Longino A, Martin K, Leyba K, Siegel G, Gill E, Douglas IS, Burke J. Correlation between the VExUS score and right atrial pressure: a pilot prospective observational study. Crit Care. 2023 May 26;27(1):205. doi: 10.1186/s13054-023-04471-0.
- Individual participant dataSharing planned: No. Prohibited from laws (and/or rules, regulations, contracts); Need a consensus from colleagues
Related trials for Acute Kidney Injury After Open Heart Surgery
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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.
Tu Huu Nguyen, Prof study chair
Hanoi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury After Open Heart Surgery and Venous Congestion After Open Heart Surgery, run by Hanoi Medical University at 1 site in Vietnam.
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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Sep 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 Vietnam. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tu Nguyen Huu, Prof (+84904176397, nguyenhuutu@hmu.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between the severity of systemic venous congestion, quantified by the VExUS grading system, and volumetric hemodynamic parameters (ELWI and GEDI) (time frame: Within the first 42 postoperative hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805564, which also lists 4 linked publications.
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 4 Sep 2026.