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

NCT07258875 | Recruiting

• 1 other identifier: 18721
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Thoracic Surgery With One-lung Ventilation; VExUS; Fluid Management; Acute Kidney Injury; Postoperative Pulmonary Complications (PPCs)

Keywords

VExUS, fluid management, pulmonary complications, acute kidney injury, thoracic surgery, one lung ventilation

Outcome Measures

Primary Outcomes (71)

• Kidney function-estimated glomerular filtration rate preoperatively

  Estimated glomerular filtration rate (eGFR) using serum creatinine, cystatin C or both calculated by CKD-EPI 2021 and MDRD equation

  preoperatively

• Kidney function-estimated glomerular filtration rate in the PACU

  Estimated glomerular filtration rate (eGFR) using serum creatinine, cystatin C or both calculated by CKD-EPI 2021 and MDRD equation

  in the PACU

• Kidney function- estimated glomerular filtration rate on postoperative day 1

  Estimated glomerular filtration rate (eGFR) using serum creatinine, cystatin C or both calculated by CKD-EPI 2021 or MDRD equation.

  postoperative day 1

• Kidney function-estimated glomerular filtration rate 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

  on postoperative day 3

• Urine output intraoperatively

  Kidney function as quantified by urine output. Data will be reported as an averaged intraoperative rate in ml/kg\*h.

  From anesthesia induction, until the end of surgery

• Urinary output postoperatively in the PACU

  Kidney function as quantified by urine output. Data will be reported as an averaged intraoperative rate in ml/kg\*h.

  during the PACU stay

• Renal stress biomarkers TIMP-2,IGFBP-7

  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.

  postoperatively in the PACU

• Serum Creatinine preoperatively

  Baseline serum creatinine measurement, in mg/dl.Blood sample collection will take place in both study groups.

  preoperatively

• Serum creatinine in the PACU

  serum creatinine measurement, in mg/dl.Blood sample collection will take place in both study groups.

  during the PACU stay

• Serum creatinine on postoperative day 1

  Serum creatine measurement in mg/dlBlood sample collection will take place in both study groups.

  postoperative day 1

• Serum creatinine on postoperative day 3

  measurement of serum creatinine in mg/dl.Blood sample collection will take place in both study groups.

  postoperative day 3

• Serum cystatin C preoperatively

  baseline measurement of serum cystatin C in mg/L.Blood sample collection will take place in both study groups.

  preoperatively

• serum cyctatin C in the PACU

  measurement of serum cystatin C postopertively in the PACU.Blood sample collection will take place in both study groups.

  during the PACU stay

• serum cystatin C on postoperative day 1

  measurement of serum cystatin C in mg/L.Blood sample collection will take place in both study groups.

  postoperative day 1

• serum cystatin C on postoperative day 3

  measurement of serum cystatin C in mg/LBlood sample collection will take place in both study groups.

  postoperative day 3

• urine beta-2 microglobulin preoperatively

  baseline measurement of beta-2 microglobulin in urine, as a renal stress marker.Urine sample collection will take place in both study groups.

  preoperatively

• urine beta-2 microglobulin in the PACU

  measurement of beta-2 microglobuline in urine.Urine sample collection will take place in both study groups.

  during the PACU stay

• urine beta-2 microglobulin on postoperative day 1

  measurement of beta-2 microglobulin in urine.Urine sample collection will take place in both study groups.

  postoperative day 1

• urine beta-2 microglobulin on postoperative day 3

  measurement of beta-2 microglobulin in urine.Urine sample collection will take place in both study groups.

  postoperative day 3

• total urine protein preoperatively

  baseline total urine protein measurement in mg/L in both groups of patients

  preoperatively

• total urine protein in the PACU

  Measurement of total urine protein in mg/l in both groups of patients

  during the PACU stay

• total urine protein on postoperative day 1

  total urine protein measurement in mg/L in both groups of patients

  postoperative day 1

• total urine protein on postoperative day 3

  measurement of total urine protein in mg/L in both groups of patients

  postoperative day 3

• urine albumin preoperatively

  baseline measurement of urine albumin in both groups of patients

  preoperatively

• urine albumin in the PACU

  urine albumin measurement in both groups of patients

  during the PACU stay

• urine albumin on postoperative day 1

  measurement of urine albumin in both groups of patients

  postoperative day 1

• urine albumin on postoperative day 3

  measurement of urine albumin in both groups of patients

  postoperative day 3

• urine creatinine preoperatively

  urine creatinine baseline measurement in g/L in both groups of patients

  preoperatively

• urine creatinine in the PACU

  urine creatinine measurement in g/L in both groups of patients

  during the PACU stay

• urine creatinine on postoperative day 1

  measurement of urine creatinine in g/l in both groups of patients

  postoperative day 1

• urine creatinine on postoperative day 3

  measurement of urine creatinine in g/l in both groups of patients

  postoperative day 3

• urine albumin to creatinine ratio preoperatively

  baseline measurement of urine albumin to creatinine ratio in both groups of patients

  preoperatively

• urine albumin to creatinine ratio in the PACU

  measurement of urine albumin to creatinine ratio in both groups of patients

  during the PACU stay

• urine albumin to creatinine ratio on postoperative day 1

  measurement of urine albumin to creatinine ratio in both groups of patients

  postoperative day 1

• urine albumin to creatinine ratio on postoperative day 3

  measurement of urine albumin to creatinine ratio in both groups of patients

  postoperative day 3

• urine protein to creatinine ratio preoperatively

  baseline measurement of urine protein to creatinine ratio in both groups of patients

  preoperatively

• urine protein to creatinine ratio in the PACU

  measurement of protein to creatinine ratio in both groups of patients

  during the PACU stay

• urine protein to creatinine ratio on postoperative day 1

  measurement of protein to creatinine ratio in both groups of patients

  postoperative day 1

• urine protein to creatinine ratio on postoperative day 3

  measurement of protein to creatinine ratio in both groups of patients

  postoperative day 3

• pulse oximetry (SpO2) preoperatively

  baseline pulse oximetry measurement in both groups of patients

  preoperatively

• pulse oximetry (SpO2) intraoperatively

  mean of pulse oximetry measurements in both groups of patients

  during one lung ventilation

• pulse oximetry (SpO2) in the PACU

  mean of pulse oximetry measurements in both groups of patients

  during the PACU stay

• pulse oximetry (SpO2) on postoperative day 1

  pulse oximetry measurement in both groups of patients

  postoperative day 1

• pulse oximetry (SpO2) on postoperative day 3

  pulse oximetry measurement in both groups of patients

  postoperative day 3

• arterial oxygen saturation (SaO2) preoperatively

  baseline measurement of arterial oxygen saturation in both groups of patients by arterial blood gas analysis

  preoperatively

• arterial oxygen saturation (SaO2) intraoperatively

  mean of measurement of arterial oxygen saturation in both groups of patients by arterial blood gas analysis

  intraoperatively

• arterial oxygen saturation (SaO2) in the PACU

  mean of measurement of arterial oxygen saturation in both groups of patients by arterial blood gas analysis

  during the PACU stay

• arterial oxygen saturation (SaO2) on postoperative day 1

  measurement of arterial oxygen saturation in both groups of patients by arterial blood gas analysis

  postoperative day 1

• arterial oxygen saturation (SaO2) on postoperative day 3

  measurement of arterial oxygen saturation in both groups of patients by arterial blood gas analysis

  postoperative day 3

• arterial carbon dioxide partial pressure (PaCO2) preoperatively

  baseline measurement of arterial carbon dioxide partial pressure in mmHg in both groups of patients

  preoperatively

• arterial carbon dioxide partial pressure intraoperatively

  mean of arterial carbon dioxide partial pressure measurements in mmHg in both groups of patients

  intraoperatively

• arterial carbon dioxide partial pressure in the PACU

  mean of arterial carbon dioxide partial pressure measurements in mmHg in both groups of patients

  during the PACU stay

• arterial carbon dioxide partial pressure on postoperative day 1

  arterial carbon dioxide partial pressure measurement in mmHg in both groups of patients

  postoperative day 1

• arterial carbon dioxide partial pressure on postoperative day 3

  arterial carbon dioxide partial pressure measurement in mmHg in both groups of patients

  postoperative day 3

• arterial oxygen partial pressure (PaO2) preoperatively

  arterial oxygen partial pressure baseline measurement in mmHg in both groups of patients

  preoperatively

• arterial oxygen partial pressure (PaO2) intraoperatively

  mean of arterial oxygen partial pressure measurements in mmHg in both groups of patients during one lung ventilation

  intraoperatively

• arterial oxygen partial pressure (PaO2) in the PACU

  mean of arterial oxygen partial pressure measurements in mmHg in both groups of patients

  during the PACU stay

• arterial oxygen partial pressure (PaO2) on postoperative day 1

  arterial oxygen partial pressure measurement in mmHg in both groups of patients

  postoperative day 1

• arterial oxygen partial pressure (PaO2) on postoperative day 3

  arterial oxygen partial pressure measurement in mmHg in both groups of patients

  postoperative day 3

• arterial lactate measurement preoperatively

  baseline measurement of arterial lactate in mmol/L by arterial blood gas analysis in both groups of patients

  preoperatively

• arterial lactate measurement intraoperatively

  mean of measurements of arterial lactate in mmol/L by arterial blood gas analysis in both groups of patients

  intraoperatively

• arterial lactate measurement in the PACU

  mean of measurements of arterial lactate in mmol/L by arterial blood gas analysis in both groups of patients

  during the PACU stay

• arterial lactate measurement on postoperative day 1

  measurement of arterial lactate in mmol/L by arterial blood gas analysis in both groups of patients

  postoperative day 1

• arterial lactate measurement on postoperative day 3

  measurement of arterial lactate in mmol/L by arterial blood gas analysis in both groups of patients

  postoperative day 3

• oxygen partial pressure to fraction of oxygen in inspired air ratio (P/F ratio) in arterial blood preoperatively

  baseline measurement of P/F ratio by arterial blood gas analysis in both groups of patients

  preoperatively

• oxygen partial pressure to fraction of oxygen in inspired air ratio (P/F ratio) in arterial blood intraoperatively

  mean of measurements of P/F ratio by arterial blood gas analysis in both groups of patients

  intraoperatively

• oxygen partial pressure to fraction of oxygen in inspired air ratio (P/F ratio) in arterial blood in the PACU

  mean of measurements of P/F ratio by arterial blood gas analysis in both groups of patients

  during the PACU stay

• oxygen partial pressure to fraction of oxygen in inspired air ratio (P/F ratio) in arterial blood on postoperative day 1

  measurement of P/F ratio by arterial blood gas analysis in both groups of patients

  postoperative day 1

• oxygen partial pressure to fraction of oxygen in inspired air ratio (P/F ratio) in arterial blood on postoperative day 3

  measurement of P/F ratio by arterial blood gas analysis in both groups of patients

  postoperative day 3

• occurrence of postoperative pulmonary complications (PCCs) 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.

  on postoperative day 1

• occurrence of postoperative pulmonary complications (PCCs) 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.

  on postoperative day 3

Secondary Outcomes (6)

• 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

Study Arms (2)

standard of care group

PLACEBO COMPARATOR

Intraoperatively patients of the control group will be administered isotonic crystalloids (Lactated Ringer's, Plasma-Lyte) at a rate of 3 mL/kg/h.Fluid administration will continue at a rate of 3 mL/kg/h as per standard practice in the postanaesthesia care unit( PACU) also.In both groups, blood losses more than 300 ml will be replaced with a 5% albumin solution at a 1:1 ratio. Transfusion will be administered to maintain hemoglobin levels at 9 mg/dL. Both groups will follow the same multimodal anesthesia-analgesia protocol, with restricted opioid use in accordance with the departmental routine. Intraoperative hypotension (systolic arterial pressure \< 90 mmHg or a decrease \> 20% from baseline) will be managed with titrated norepinephrine infusion.

Other: Standard of Care (SOC)

vexus guided group

ACTIVE COMPARATOR

The VExUS evaluation will be performed pre- and immediately post-intubation before one-lung ventilation initiation. Ultrasound monitoring will be performed according to the VExUS protocol before positioning the patient in the lateral decubitus position. In patients with VExUS grade 0, a bolus of 250-500 mL (approximately 3 mL/kg) will be administered, followed by the infusion of crystalloids at a rate of 3 mL/kg/h. The inferior vena cava (IVC) diameter will be measured three times: once prior to anesthesia induction, once immediately after intubation, and once before patient emergence from anesthesia. In patients with VExUS grade 1, no bolus will be given, and only a fluid infusion at 3 mL/kg/h will be administered. In patients with VExUS grades 2 and 3, 10 mg of furosemide will be administered intravenously, followed by crystalloids infusion at a rate of 2 mL/kg/h.VExUS ultrasound will be repeated postoperatively in the PACU, following the same pattern of intervention.

Diagnostic Test: Venous Excess Ultrasound

Interventions

Venous Excess Ultrasound DIAGNOSTIC_TEST

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)

Also known as: VEXUS

vexus guided group

Standard of Care (SOC) OTHER

Intraoperatively patients of the control group will be administered isotonic crystalloids (Lactated Ringer's, Plasma-Lyte) at a rate of 3 mL/kg/h.Fluid administration will continue at a rate of 3 mL/kg/h as per standard practice in the PACU.

Also known as: standard of care

standard of care group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>18 years undergoing video assisted thoracic surgery/ lobectomy requiring one-lung ventilation.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Crete: lead

Study Sites (1)

University General Hospital of Heraklion

Heraklion, Crete, 71500, Greece

RECRUITING

Related Publications (12)

• Dharnidharka VR, Kwon C, Stevens G. Serum cystatin C is superior to serum creatinine as a marker of kidney function: a meta-analysis. Am J Kidney Dis. 2002 Aug;40(2):221-6. doi: 10.1053/ajkd.2002.34487.

  PMID: 12148093 RESULT

• 13. Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury Work vexusGroup. KDIGO Clinical Practice Guideline for Acute Kidney Injury. Kidney inter., Suppl. 2012; 2: 1-138.

  RESULT

• Jammer I, Wickboldt N, Sander M, Smith A, Schultz MJ, Pelosi P, Leva B, Rhodes A, Hoeft A, Walder B, Chew MS, Pearse RM; European Society of Anaesthesiology (ESA) and the European Society of Intensive Care Medicine (ESICM); European Society of Anaesthesiology; European Society of Intensive Care Medicine. Standards for definitions and use of outcome measures for clinical effectiveness research in perioperative medicine: European Perioperative Clinical Outcome (EPCO) definitions: a statement from the ESA-ESICM joint taskforce on perioperative outcome measures. Eur J Anaesthesiol. 2015 Feb;32(2):88-105. doi: 10.1097/EJA.0000000000000118.

  PMID: 25058504 RESULT

• Longino 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.

  PMID: 37237315 RESULT

• Magin JC, Wrobel JR, An X, Acton J, Doyal A, Jia S, Krakowski JC, Schoenherr J, Serrano R, Flynn D, McLean D, Grant SA. Venous Excess Ultrasound (VExUS Grading to Assess Perioperative Fluid Status for Noncardiac Surgeries: a Prospective Observational Pilot Study. POCUS J. 2023 Nov 27;8(2):223-229. doi: 10.24908/pocus.v8i2.16792. eCollection 2023.

  PMID: 38099161 RESULT

• Beaubien-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.

  PMID: 32270297 RESULT

• Romagnoli S, Ricci Z. Postoperative acute kidney injury. Minerva Anestesiol. 2015 Jun;81(6):684-96. Epub 2014 Jul 24.

  PMID: 25057935 RESULT

• Park M, Yoon S, Nam JS, Ahn HJ, Kim H, Kim HJ, Choi H, Kim HK, Blank RS, Yun SC, Lee DK, Yang M, Kim JA, Song I, Kim BR, Bahk JH, Kim J, Lee S, Choi IC, Oh YJ, Hwang W, Lim BG, Heo BY. Driving pressure-guided ventilation and postoperative pulmonary complications in thoracic surgery: a multicentre randomised clinical trial. Br J Anaesth. 2023 Jan;130(1):e106-e118. doi: 10.1016/j.bja.2022.06.037. Epub 2022 Aug 20.

  PMID: 35995638 RESULT

• Lohser J, Slinger P. Lung Injury After One-Lung Ventilation: A Review of the Pathophysiologic Mechanisms Affecting the Ventilated and the Collapsed Lung. Anesth Analg. 2015 Aug;121(2):302-18. doi: 10.1213/ANE.0000000000000808.

  PMID: 26197368 RESULT

• Arslantas MK, Kara HV, Tuncer BB, Yildizeli B, Yuksel M, Bostanci K, Bekiroglu N, Kararmaz A, Cinel I, Batirel HF. Effect of the amount of intraoperative fluid administration on postoperative pulmonary complications following anatomic lung resections. J Thorac Cardiovasc Surg. 2015 Jan;149(1):314-20, 321.e1. doi: 10.1016/j.jtcvs.2014.08.071. Epub 2014 Sep 18.

  PMID: 25304302 RESULT

• Tarbell JM. Shear stress and the endothelial transport barrier. Cardiovasc Res. 2010 Jul 15;87(2):320-30. doi: 10.1093/cvr/cvq146. Epub 2010 Jun 12.

  PMID: 20543206 RESULT

• Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.

  PMID: 30304509 RESULT

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alexandra Papaioannou, Professor of Anaesthesiology

  Medical School, University of Crete

  STUDY CHAIR

Central Study Contacts

Alexandros Bogas Manouselis, Resident of Anaesthesiology

CONTACT

+306947545446; bogas.alexandros@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alexandros Bogas Manouselis

Model Details: A single-center clinical study conducted in the Anesthesiology Clinic of the University General Hospital of Heraklion. Parallel design in two groups.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: November 27, 2024
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-10

Locations

GR (1)