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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Crete

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Refusal to participate.

Pneumonectomy.

Young athletes (risk of physiologically large IVC >2 cm).

Moderate-severe tricuspid regurgitation, moderate to severe pulmonary hypertension

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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)

  • Standard of Care (SOC)

    Other intervention

    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.

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: standard of care groupPlacebo comparator 1 intervention
Group B: vexus guided groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
preoperatively
2

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

Time frame
in the PACU
3

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.

Time frame
postoperative day 1
4

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

Time frame
on postoperative day 3

Secondary outcomes

1

long term kidney impairment

serum and urine creatinine, serum urea, urine albumin and protein and consequently albumin to creatinine ratio and protein to creatinine ratio will be measured approximately 30 days postoperative, to asses long term renal dysfunction after VATS lobectomy.

Time frame
from enrollment to day 30 approximately
2

Noradrenaline equivalent dose

Both groups maintained stable blood pressures with norepinephrine support as needed, but VExUS group showed more hemodynamic stability, concerning the measurements of cardiac output, cardiac index, stroke volume and stroke volume variation ( pulse contour analysis). As though, a larger noradrenaline amount as total dose and consequently, a bigger noradrenaline equivalent dose is expected to be given perioperatively in the control group of standard of care.

Time frame
from the surgery onset to the discharge from the post anesthesia care unit
3

Length of stay - Hospital Discharge

Hospital length of stay will be reported in days.

Time frame
From date of randomization (day before surgery) until the date of the discharge from the hospital
4

intraoperative hypotension

Intraoperative Hypotension (defined as MAP≤65mmHg or ≤80% of preoperative Baseline), with episodes lasting ≥1 minute. All patients will have a 5 minute preoperative MAP baseline, with measurements every 20 seconds. Intraoperative data will be compared to the mean preoperative 5 minute MPB baseline.

Time frame
Baseline: 5 minutes prior to anaesthesia induction. Intraoperative Hypotension: From anesthesia induction, until the end of surgery

Other outcomes

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