Recruiting

VEXUSVExUS Ultrasound for Fluid Management in Thoracic Surgery

Study Aim

This study aims to evaluate the use of VExUS ultrasound in managing fluid levels during thoracic surgery to prevent complications and improve recovery outcomes.

What is being tested

Venous Excess Ultrasound

+ Standard of Care (SOC)

Diagnostic TestOther

Who is being recruted

Urogenital Diseases+5

+ Female Urogenital Diseases and Pregnancy Complications

+ Kidney Diseases

Over 18 Years

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-Controlled

Interventional

Study Start: November 2024

See protocol details

Summary

Principal SponsorUniversity of Crete

Study ContactAlexandros Bogas Manouselis, Resident of Anaesthesiology

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 27, 2024

Actual date on which the first participant was enrolled.

This study focuses on patients undergoing thoracic surgery, who are at risk of developing lung and kidney complications due to the management of fluids during and after surgery. The main aim is to see if using a special ultrasound method called the VExUS protocol can help manage these fluids better, reducing the chances of complications like lung problems and acute kidney injury. This is important because managing fluids incorrectly can lead to serious issues like acute respiratory distress syndrome (ARDS) or kidney damage, which can prolong hospital stays and increase the risk of death. Participants in this study are divided into two groups. One group receives standard fluid management, while the other group has their fluid levels managed using the VExUS protocol, which involves ultrasound checks of certain veins to assess fluid congestion. The study measures a variety of outcomes including blood gas levels, kidney function, and the presence of postoperative respiratory complications. Fluid management is carefully tracked, and adjustments are made based on the VExUS score, with some patients receiving medications like furosemide to help control fluid levels. This approach aims to optimize fluid balance, reduce complications, and improve recovery after surgery.

Official TitleEffect 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

Principal SponsorUniversity of Crete

Study ContactAlexandros Bogas Manouselis, Resident of Anaesthesiology

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

230 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesAcute Kidney Injury

Criteria

Inclusion Criteria: * Adults \>18 years undergoing video assisted thoracic surgery/ lobectomy requiring one-lung ventilation. Exclusion Criteria: * 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)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

Placebo

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University General Hospital of Heraklion

Heraklion, GreeceOpen University General Hospital of Heraklion in Google Maps

Recruiting

One Study Center