NCT07232277

Venous Congestion and Cardiac Surgery-Associated Acute Kidney Injury

Intraoperative Venous Congestion and Cardiac Surgery-associated Acute Kidney Injury (CSA-AKI): a Prospective Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 114 (estimated)
• Sponsor: Zhuan Zhang · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	collection of demographic characteristics and comorbidities	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.
OTHER	surgery-related parameters and kidney function assessments	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.
OTHER	collection of biological (laboratory) parameters	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.
OTHER	collection of hemodynamic parameters	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.
OTHER	collection of echocardiographic parameters and venous ultrasound assessments	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.

Timeline

• Start date: 2024-10-15
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: China