Effect of VExUS Ultrasound Protocol (Venous Excess Ultrasound) on Perioperative Fluid Management, on the Incidence of Postoperative Pulmonary Complications and Postoperative Acute Kidney Injury in Patients Undergoing Thoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Kidney function-estimated glomerular filtration rate preoperatively
研究概览
简要总结
This study aims to investigate the effect of a VExUS ultrasound guided protocol of perioperative fluid management within a goal-directed therapy framework, on postoperative respiratory complications, and the occurrence of acute kidney injury (AKI) in patients undergoing thoracic surgery.
详细描述
In thoracic surgery, intraoperative fluid management presents a challenge for anesthesiologists, as patients are at high risk of developing interstitial and alveolar edema of the lungs. A history of pulmonary disease, previous chemotherapy or radiation therapy in the area, one-lung ventilation, surgical manipulation, and ischemia-reperfusion injury can all damage the respiratory epithelium's glycocalyx, the alveolar epithelium, and surfactant, ultimately leading to pulmonary injury. These factors, combined with liberal perioperative fluid management, increase the risk of acute respiratory distress syndrome (ARDS), atelectasis, pneumonia, and ultimately postoperative mortality. Traditionally, a restrictive fluid management strategy is employed intraoperatively, with crystalloid administration at a rate of 1-2 ml/kg/h, ensuring that the perioperative fluid balance does not exceed 1500 ml. This restrictive strategy may increase the risk of hypovolemia, which can lead to tissue hypoperfusion, target organ dysfunction, and acute kidney injury. Within the Enhanced Recovery After Surgery (ERAS) protocols, goal-directed therapy (GDT) for fluid management in thoracic surgery is discussed but not explicitly recommended. Recommendations include avoiding overly restrictive or completely liberal fluid strategies, maintaining euvolemia, and preventing tissue hypoperfusion with balanced use of inotropic agents and fluid administration.
Pulmonary injury is the leading cause of death following thoracic surgery. Pre-existing respiratory disease, surgical manipulation, lung parenchyma resection, and the detrimental effects of one-lung ventilation increase the risk of postoperative respiratory complications. Although overhydration and ventilation with high tidal volumes have been replaced by a restrictive fluid strategy and the application of protective mechanical ventilation, it appears that all factors involved in ventilator-induced lung injury (VILI) also play a harmful role in one-lung ventilation. High strain on the ventilated lung, oxidative stress, surgical trauma, recruitment maneuvers, biological trauma, atelectatic trauma, and ischemia-reperfusion injury are the pathophysiological mechanisms leading to postoperative acute respiratory failure and, in 2-5% of cases, to ARDS.
Postoperative acute kidney injury (AKI) represents 18-47% of in-hospital AKI and is associated with prolonged hospitalization and high morbidity and mortality. Recently, the implementation of new AKI classifications (RIFLE, AKIN, KDIGO) has facilitated its early recognition for immediate preventive measures. Additionally, the detection of two early urinary biomarkers of kidney stress, the tissue inhibitor of metalloproteinases-2 (TIMP-2) and the insulin-like growth factor-binding protein 7 (IGFBP7), has contributed to this. Postoperatively, an increase in serum creatinine by up to 0.5 mg/dL from baseline has been associated with a threefold increase in mortality following cardiac surgery. Potential pathophysiological mechanisms of postoperative AKI include ischemia, inflammation, and toxins. However, in thoracic surgeries, both the hypovolemia of a restrictive fluid administration strategy and overhydration and venous congestion can equally lead to acute kidney injury postoperatively.
The VExUS protocol is a standardized point-of-care ultrasound examination that includes measurements of the inferior vena cava (IVC) diameter, combined with Doppler analysis of waveforms in the hepatic vein, portal vein, and renal veins. From this analysis, the presence of venous congestion-classified as mild or severe-or its absence is determined. A high VExUS score (grade 3) has been strongly associated with the occurrence of acute kidney injury in patients undergoing cardiac surgery and has more recently been linked to elevated right atrial pressure (RAP ≥ 12 mmHg). The protocol includes the following classification:
Grade 0: IVC < 2 cm Grade 1: IVC ≥ 2 cm, with normal or mildly abnormal waveforms in the hepatic, portal, and renal veins (mild congestion) Grade 2: IVC ≥ 2 cm, with severely altered waveforms in at least one vein (moderate congestion) Grade 3: IVC ≥ 2 cm, with severely altered waveforms in multiple veins (severe congestion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults >18 years undergoing video assisted thoracic surgery/ lobectomy requiring one-lung ventilation.
排除标准
- •Refusal to participate.
- •Pneumonectomy.
- •Young athletes (risk of physiologically large IVC >2 cm).
- •Moderate-severe tricuspid regurgitation, moderate to severe pulmonary hypertension
- •Heart failure with reduced ejection fraction, EF<35%
- •Portal hypertension, portal vein thrombosis, or liver cirrhosis.
- •Stage 4 or end-stage chronic kidney disease (eGFR <30 mL/min/1.73 m² or dialysis).
- •Transfusion with more than 2 packed red blood cells unit perioperatively (intraoperatively, in the PACU, in the ward)
结局指标
主要结局
Kidney function-estimated glomerular filtration rate preoperatively
时间窗: preoperatively
Estimated glomerular filtration rate (eGFR) using serum creatinine, cystatin C or both calculated by CKD-EPI 2021 and MDRD equation
Kidney function-estimated glomerular filtration rate on postoperative day 3
时间窗: on postoperative day 3
Estimated glomerular filtration rate (eGFR) using serum creatinine, cystatin C or both calculated by tha CKD-EPI 2021 and MDRD equation
Kidney function-estimated glomerular filtration rate in the PACU
时间窗: in the PACU
Estimated glomerular filtration rate (eGFR) using serum creatinine, cystatin C or both calculated by CKD-EPI 2021 and MDRD equation
Kidney function- estimated glomerular filtration rate on postoperative day 1
时间窗: postoperative day 1
Estimated glomerular filtration rate (eGFR) using serum creatinine, cystatin C or both calculated by CKD-EPI 2021 or MDRD equation.
Urine output intraoperatively
时间窗: From anesthesia induction, until the end of surgery
Kidney function as quantified by urine output. Data will be reported as an averaged intraoperative rate in ml/kg\*h.
Urinary output postoperatively in the PACU
时间窗: during the PACU stay
Kidney function as quantified by urine output. Data will be reported as an averaged intraoperative rate in ml/kg\*h.
Renal stress biomarkers TIMP-2,IGFBP-7
时间窗: postoperatively in the PACU
The detection of two early urinary biomarkers of kidney stress, the tissue inhibitor of metalloproteinases-2 (TIMP-2) and the insulin-like growth factor-binding protein 7 (IGFBP7), has contributed to early diagnosis of AKI and renal stress.Urine sample collection will take place in both study groups.
Serum Creatinine preoperatively
时间窗: preoperatively
Baseline serum creatinine measurement, in mg/dl.Blood sample collection will take place in both study groups.
Serum creatinine in the PACU
时间窗: during the PACU stay
serum creatinine measurement, in mg/dl.Blood sample collection will take place in both study groups.
Serum creatinine on postoperative day 1
时间窗: postoperative day 1
Serum creatine measurement in mg/dlBlood sample collection will take place in both study groups.
Serum creatinine on postoperative day 3
时间窗: postoperative day 3
measurement of serum creatinine in mg/dl.Blood sample collection will take place in both study groups.
Serum cystatin C preoperatively
时间窗: preoperatively
baseline measurement of serum cystatin C in mg/L.Blood sample collection will take place in both study groups.
serum cyctatin C in the PACU
时间窗: during the PACU stay
measurement of serum cystatin C postopertively in the PACU.Blood sample collection will take place in both study groups.
serum cystatin C on postoperative day 1
时间窗: postoperative day 1
measurement of serum cystatin C in mg/L.Blood sample collection will take place in both study groups.
serum cystatin C on postoperative day 3
时间窗: postoperative day 3
measurement of serum cystatin C in mg/LBlood sample collection will take place in both study groups.
urine beta-2 microglobulin preoperatively
时间窗: preoperatively
baseline measurement of beta-2 microglobulin in urine, as a renal stress marker.Urine sample collection will take place in both study groups.
urine beta-2 microglobulin in the PACU
时间窗: during the PACU stay
measurement of beta-2 microglobuline in urine.Urine sample collection will take place in both study groups.
urine beta-2 microglobulin on postoperative day 1
时间窗: postoperative day 1
measurement of beta-2 microglobulin in urine.Urine sample collection will take place in both study groups.
urine beta-2 microglobulin on postoperative day 3
时间窗: postoperative day 3
measurement of beta-2 microglobulin in urine.Urine sample collection will take place in both study groups.
total urine protein preoperatively
时间窗: preoperatively
baseline total urine protein measurement in mg/L in both groups of patients
total urine protein in the PACU
时间窗: during the PACU stay
Measurement of total urine protein in mg/l in both groups of patients
total urine protein on postoperative day 1
时间窗: postoperative day 1
total urine protein measurement in mg/L in both groups of patients
total urine protein on postoperative day 3
时间窗: postoperative day 3
measurement of total urine protein in mg/L in both groups of patients
urine albumin preoperatively
时间窗: preoperatively
baseline measurement of urine albumin in both groups of patients
urine albumin in the PACU
时间窗: during the PACU stay
urine albumin measurement in both groups of patients
urine albumin on postoperative day 1
时间窗: postoperative day 1
measurement of urine albumin in both groups of patients
urine albumin on postoperative day 3
时间窗: postoperative day 3
measurement of urine albumin in both groups of patients
urine creatinine preoperatively
时间窗: preoperatively
urine creatinine baseline measurement in g/L in both groups of patients
urine creatinine in the PACU
时间窗: during the PACU stay
urine creatinine measurement in g/L in both groups of patients
urine creatinine on postoperative day 1
时间窗: postoperative day 1
measurement of urine creatinine in g/l in both groups of patients
urine creatinine on postoperative day 3
时间窗: postoperative day 3
measurement of urine creatinine in g/l in both groups of patients
urine albumin to creatinine ratio preoperatively
时间窗: preoperatively
baseline measurement of urine albumin to creatinine ratio in both groups of patients
urine albumin to creatinine ratio in the PACU
时间窗: during the PACU stay
measurement of urine albumin to creatinine ratio in both groups of patients
urine albumin to creatinine ratio on postoperative day 1
时间窗: postoperative day 1
measurement of urine albumin to creatinine ratio in both groups of patients
urine albumin to creatinine ratio on postoperative day 3
时间窗: postoperative day 3
measurement of urine albumin to creatinine ratio in both groups of patients
urine protein to creatinine ratio preoperatively
时间窗: preoperatively
baseline measurement of urine protein to creatinine ratio in both groups of patients
urine protein to creatinine ratio in the PACU
时间窗: during the PACU stay
measurement of protein to creatinine ratio in both groups of patients
urine protein to creatinine ratio on postoperative day 1
时间窗: postoperative day 1
measurement of protein to creatinine ratio in both groups of patients
urine protein to creatinine ratio on postoperative day 3
时间窗: postoperative day 3
measurement of protein to creatinine ratio in both groups of patients
pulse oximetry (SpO2) preoperatively
时间窗: preoperatively
baseline pulse oximetry measurement in both groups of patients
pulse oximetry (SpO2) intraoperatively
时间窗: during one lung ventilation
mean of pulse oximetry measurements in both groups of patients
pulse oximetry (SpO2) in the PACU
时间窗: during the PACU stay
mean of pulse oximetry measurements in both groups of patients
pulse oximetry (SpO2) on postoperative day 1
时间窗: postoperative day 1
pulse oximetry measurement in both groups of patients
pulse oximetry (SpO2) on postoperative day 3
时间窗: postoperative day 3
pulse oximetry measurement in both groups of patients
arterial oxygen saturation (SaO2) preoperatively
时间窗: preoperatively
baseline measurement of arterial oxygen saturation in both groups of patients by arterial blood gas analysis
arterial oxygen saturation (SaO2) intraoperatively
时间窗: intraoperatively
mean of measurement of arterial oxygen saturation in both groups of patients by arterial blood gas analysis
arterial oxygen saturation (SaO2) in the PACU
时间窗: during the PACU stay
mean of measurement of arterial oxygen saturation in both groups of patients by arterial blood gas analysis
arterial oxygen saturation (SaO2) on postoperative day 1
时间窗: postoperative day 1
measurement of arterial oxygen saturation in both groups of patients by arterial blood gas analysis
arterial oxygen saturation (SaO2) on postoperative day 3
时间窗: postoperative day 3
measurement of arterial oxygen saturation in both groups of patients by arterial blood gas analysis
arterial carbon dioxide partial pressure (PaCO2) preoperatively
时间窗: preoperatively
baseline measurement of arterial carbon dioxide partial pressure in mmHg in both groups of patients
arterial carbon dioxide partial pressure intraoperatively
时间窗: intraoperatively
mean of arterial carbon dioxide partial pressure measurements in mmHg in both groups of patients
arterial carbon dioxide partial pressure in the PACU
时间窗: during the PACU stay
mean of arterial carbon dioxide partial pressure measurements in mmHg in both groups of patients
arterial carbon dioxide partial pressure on postoperative day 1
时间窗: postoperative day 1
arterial carbon dioxide partial pressure measurement in mmHg in both groups of patients
arterial carbon dioxide partial pressure on postoperative day 3
时间窗: postoperative day 3
arterial carbon dioxide partial pressure measurement in mmHg in both groups of patients
arterial oxygen partial pressure (PaO2) preoperatively
时间窗: preoperatively
arterial oxygen partial pressure baseline measurement in mmHg in both groups of patients
arterial oxygen partial pressure (PaO2) intraoperatively
时间窗: intraoperatively
mean of arterial oxygen partial pressure measurements in mmHg in both groups of patients during one lung ventilation
arterial oxygen partial pressure (PaO2) in the PACU
时间窗: during the PACU stay
mean of arterial oxygen partial pressure measurements in mmHg in both groups of patients
arterial oxygen partial pressure (PaO2) on postoperative day 1
时间窗: postoperative day 1
arterial oxygen partial pressure measurement in mmHg in both groups of patients
arterial oxygen partial pressure (PaO2) on postoperative day 3
时间窗: postoperative day 3
arterial oxygen partial pressure measurement in mmHg in both groups of patients
arterial lactate measurement preoperatively
时间窗: preoperatively
baseline measurement of arterial lactate in mmol/L by arterial blood gas analysis in both groups of patients
arterial lactate measurement intraoperatively
时间窗: intraoperatively
mean of measurements of arterial lactate in mmol/L by arterial blood gas analysis in both groups of patients
arterial lactate measurement in the PACU
时间窗: during the PACU stay
mean of measurements of arterial lactate in mmol/L by arterial blood gas analysis in both groups of patients
arterial lactate measurement on postoperative day 1
时间窗: postoperative day 1
measurement of arterial lactate in mmol/L by arterial blood gas analysis in both groups of patients
arterial lactate measurement on postoperative day 3
时间窗: postoperative day 3
measurement of arterial lactate in mmol/L by arterial blood gas analysis in both groups of patients
oxygen partial pressure to fraction of oxygen in inspired air ratio (P/F ratio) in arterial blood preoperatively
时间窗: preoperatively
baseline measurement of P/F ratio by arterial blood gas analysis in both groups of patients
oxygen partial pressure to fraction of oxygen in inspired air ratio (P/F ratio) in arterial blood intraoperatively
时间窗: intraoperatively
mean of measurements of P/F ratio by arterial blood gas analysis in both groups of patients
oxygen partial pressure to fraction of oxygen in inspired air ratio (P/F ratio) in arterial blood in the PACU
时间窗: during the PACU stay
mean of measurements of P/F ratio by arterial blood gas analysis in both groups of patients
oxygen partial pressure to fraction of oxygen in inspired air ratio (P/F ratio) in arterial blood on postoperative day 1
时间窗: postoperative day 1
measurement of P/F ratio by arterial blood gas analysis in both groups of patients
oxygen partial pressure to fraction of oxygen in inspired air ratio (P/F ratio) in arterial blood on postoperative day 3
时间窗: postoperative day 3
measurement of P/F ratio by arterial blood gas analysis in both groups of patients
occurrence of postoperative pulmonary complications (PCCs) on postoperative day 1
时间窗: on postoperative day 1
Patients will be monitored for the occurrence of postoperative respiratory complications as defined by the European Society of Anaesthesiology, including aspiration pneumonitis, respiratory failure, ARDS, pulmonary infection, atelectasis, cardiopulmonary edema, pleural infusion, pneumothorax, pulmonary infiltrates, prolonged air leakage, purulent pleuritis, pulmonary embolism, lung hemorrhage and bronchospasm. Chest radiography obtaining on postoperative day 1, arterial blood gas analysis as already mentioned and clinical findings such as respiratory rate, heart rate, blood pressure, temperature, airway secretions, Visual analog scale of dyspnea will help to identify the presence or not of PCCs.
occurrence of postoperative pulmonary complications (PCCs) on postoperative day 3
时间窗: on postoperative day 3
Patients will be monitored for the occurrence of postoperative respiratory complications as defined by the European Society of Anaesthesiology, including aspiration pneumonitis, respiratory failure, ARDS, pulmonary infection, atelectasis, cardiopulmonary edema, pleural infusion, pneumothorax, pulmonary infiltrates, prolonged air leakage, purulent pleuritis, pulmonary embolism, lung hemorrhage and bronchospasm. Chest radiography obtaining on postoperative day 3 or earlier, arterial blood gas analysis as already mentioned and clinical findings such as respiratory rate, heart rate, blood pressure, temperature, airway secretions, Visual analog scale of dyspnea will help to identify the presence or not of PCCs.
次要结局
- long term kidney impairment(from enrollment to day 30 approximately)
- Noradrenaline equivalent dose(from the surgery onset to the discharge from the post anesthesia care unit)
- Length of stay - Hospital Discharge(From date of randomization (day before surgery) until the date of the discharge from the hospital)
- intraoperative hypotension(Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery)
- hemodynamic stability: pulse contour analysis monitoring(Baseline: 5 minutes prior to anaesthesia induction.From anesthesia induction, until the end of surgery)
- RBCs tranfusion, FFP transfusion, PLT tranfusion intraoperatively(From anesthesia induction, until the end of surgery)
研究者
Alexandros Bogas
Alexandros Bogas Manouselis
University of Crete