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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Venous Excess Ultrasound
Diagnostic testThe 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 interventionIntraoperatively 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
Trial outcomes
Primary outcomes
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
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
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.
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
Secondary outcomes
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.
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.
Length of stay - Hospital Discharge
Hospital length of stay will be reported in days.
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.
Sponsors and contacts
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