Venous Congestion and Cardiac Surgery-Associated Acute Kidney Injury

NCT07232277 | Recruiting DMC

• 1 other identifier: 20240916
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Venous pressure is often overlooked as an important hemodynamic parameter. Elevated venous pressure and blood stasis in organ tissues can lead to interstitial edema. Intraoperative venous blood stasis can rapidly increase interstitial pressures within organ tissues, especially in organs encapsulated by tissue envelopes, such as the kidney, thereby rapidly reducing effective circulating blood flow to the organ. Systemic venous blood stasis, which tends to occur in patients with right heart failure or pulmonary hypertension, as well as in patients with fluid overload, can lead to intraoperative stasis in multiple organs and tissues, mediating the development of multisystem complications, including acute kidney injury. Therefore, timely, effective, and accurate intraoperative assessment of systemic venous blood stasis is particularly important. When right heart failure and/or volume overload occurs in the body, changes in right atrial pressure are transmitted to the venous system of organs throughout the body, with dilatation of the inferior vena cava (IVC), obstruction of blood return from the hepatic, portal, and renal veins, and abnormal venous flow signals and altered ultrasound Doppler flow patterns. The primary objective of this prospective cohort study is to explore if intraoperative systemic venous congestion during cardiac surgery is associated with postoperative CSA-AKI. In doing so, we seek to identify a promising physiological marker that can provide cues for the prediction of CSA-AKI. This study will also investigate the relationship between intraoperative systemic venous congestion and postoperative complications, and explore the relationship between each separate venous congestion and AKI after cardiac surgery.

Conditions

Intraoperative; Venous Congestion; Cardiac Surgery-associated Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury defined by an increase in serum creatinine of ≥150% of baseline or an elevation of 0.3 mg/dL or more within a contiguous period of 48 hours. (KDIGO criteria)

  7 days after surgery

Study Arms (1)

Participant

Adult patients scheduled to undergo elective cardiac surgery

Other: collection of demographic characteristics and comorbidities; Other: surgery-related parameters and kidney function assessments; Other: collection of biological (laboratory) parameters; Other: collection of hemodynamic parameters; Other: collection of echocardiographic parameters and venous ultrasound assessments

Interventions

collection of demographic characteristics and comorbidities OTHER

1. gender, age, BMI, ASA classification, NYHA (New York Heart Association) classification. 2. smoking history, medical history (hypertension, diabetes mellitus, Hyperlipidemia, stroke, anaemia, chronic obstructive pulmonary disease, pulmonary hypertension, preoperative atrial fibrillation, peripheral artery disease), preoperative ACEI, ARB, beta-blockers, loop diuretics, contrast agent, aspirin, and spironolactone use.

Participant

surgery-related parameters and kidney function assessments OTHER

1. surgery type, surgery duration, CPB duration, aortic cross-clamp duration, blood loss, intraoperative fluid infusion, intraoperative urine output, intraoperative blood transfusion, intraoperative anesthetics and vasoactive medications. 2. baseline and postoperative eGFR, duration of mechanical ventilation, duration of vasopressor support, postoperative CRRT initiation, major bleeding, deep sternal wound infection/mediastinitis, surgical re-intervention, ICU LOS, hospital LOS, postoperative stroke, postoperative delirium, complications up to 30 days after surgery, 30-day inpatient mortality, survival status at discharge, and one year follow-up. 3. a composite endpoint of major complications after surgery defined as at least one of the following: death, prolonged ventilation (\>24 h), stroke, severe AKI, deep sternal wound infection, and reoperation for any reason. 4. CSA-AKI diagnosed using the KDIGO criteria. 5. acute kidney disease assessment. 6. major adverse kidney events.

Participant

collection of biological (laboratory) parameters OTHER

1. WBC, CRP, IL-6, IL-1β, TNF-α, serum Amyloid A, procalcitonin, catecholamines, cortisol, SOD. 2. creatinine, uric acid, BUN, CysC, β2-MG, eGFR. 3. CK-MB, high-sensitivity troponin, NT pro-BNP, BNP. 4. hemoglobin, hematocrit, sodium, arterial lactate, liver enzymes.

Participant

collection of hemodynamic parameters OTHER

1. blood pressure, heart rate, CVP; 2. CO, CI, SV, SVI,SVV; 3. intra-abdominal pressure; 4. vasoactive drug doses in the first hour in the ICU.

Participant

collection of echocardiographic parameters and venous ultrasound assessments OTHER

1. Left ventricle systolic function, including LVOT, LVEF, MPI; left ventricular diastolic function, including mitral flow-derived Doppler indices, pulmonary vein Doppler indices. 2. Right ventricular systolic function, including TAPSE. Right ventricular diastolic function, inferred from an hepatic vein flow in the absence of a dysrhythmia or pacing. 3. Inferior vena cava (IVC) measurements. 4. Hepatic vein Doppler parameters. 5. Portal vein Doppler parameters. 6. Renal vein Doppler parameters. 7. Renal artery blood flow Doppler parameters.

Participant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled to undergo elective cardiac surgery

You may qualify if:

• Patients scheduled to undergo elective cardiac surgery;
• ≥ 18 years.

You may not qualify if:

• Contraindications for TEE;
• Emergency cardiac surgery;
• Major vascular surgery;
• Redo cardiac surgery;
• Abnormal preoperative renal function;
• Severe chronic kidney disease (estimated glomerular filtration rate \< 15 ml/min/1.73 m2 or dialysis);
• History of kidney transplantation;
• Severe infection requiring continuous antibiotic therapy；
• Severe preoperative heart failure with left ventricular ejection fraction \< 30%;
• A critical preoperative state (mechanical circulatory support, extracorporeal membrane oxygenation, current renal replacement therapy \[RRT\], mechanical ventilation, or cardiac arrest necessitating resuscitation);
• Multi-organ dysfunction;
• Known conditions that may interfere with the assessment or interpretation of hepatic vein, portal vein blood flow (such as liver cirrhosis or portal vein thrombosis) or the renal vein blood flow and renal artery blood flow (such as urinary tract obstruction);
• Planned cardiac transplantation or ventricular assist device implantation;
• Pregnancy;
• Insufficient ultrasonographic imaging;

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

No. 368 Hanjiang Middle Road

Yangzhou, Jiangsu, 225012, China

RECRUITING

MeSH Terms

Conditions

Hyperemia

Interventions

Comorbidity; Laboratories

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Non-Medical Public and Private Facilities; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Zhuan Zhang, MD

  The Department of Anesthesiology, The Affiliated Hospital of Yangzhou University, Yangzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuan Zhang, MD

CONTACT

+8615062791355; zhangzhuancg@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, the Deputy Director of Anesthesiology, the Affiliated Hospital of Yangzhou University, Yangzhou University

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: November 18, 2025
• Study Start: October 15, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)