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Recruiting Observational

Blood Velocity Variation in Right Renal and Superior Mesenteric Arteries During Cardio-pulmonary Bypass

NCT06009809 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2022-02-15
Last updated
2025-12-01

Condition(s) studied

Heart Surgical Procedure

Investigational drug(s) / intervention(s)

transesophageal echocardiogram

transesophageal echocardiogram: To measure mean blood velocity at the level of the right renal and superior mesenteric artery

Study summary

The cardiopulmonary by-pass technique, used in cardiac surgery to obtain a bloodless operating field and an immobile heart, determines important effects on the blood vessel wall, especially when a continuous and non-continuous blood flow is used. In fact, a reduction in Nitric Oxide (NO) production by the endothelium, an increase in systemic vascular resistance and an increased risk of cerebral and renal hypoperfusion have been observed and can result in potential organ damage. Acute kidney injury (AKI) after heart surgery is a major cause of mortality and morbidity. Its incidence varies according to different definitions, but can reach 30%. In some series, 1-5% of patients require renal replacement therapy in the postoperative period presenting a mortality that can reach 50-70%. However, even more limited increases in serum creatinine are associated with worsening prognosis and the risk of chronic kidney disease. The pathophysiology of AKI in cardiac surgery is complex and still partly unknown.Recently a technique has been described that allows to measure the blood velocity in the right renal artery and in the superior mesenteric artery using the transesophageal echocardiogram (TEE); this technique allows to view these arteries and measure the speed of the blood with good precision because the insonation angle (ie the angle formed by the ultrasound flow and the direction of the blood vessel) is adequate. In cardiac surgery, this methodology allows you to monitor blood velocity in the right renal artery and superior mesenteric artery during surgery. Some authors have used it to conduct pilot studies in which the blood velocity values in the renal arteries during cardiac surgery were used to calculate the pulsatility and resistivity indices, as predictors of the risk of postoperative AKI. At present, therefore, despite the fact that TEE is routinely used for monitoring renal perfusion during cardiac surgery, the blood velocity in the renal and mesenteric arteries has been little studied during cardiopulmonary by-pass (CPB) and has never been evaluated during CPB with continuous flow; in particular, the possible variation in blood velocity measured during CPB compared to the baseline values measured before extracorporeal circulation and its correlation with the onset of postoperative renal failure is not known.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * age\> 18 years * written informed consent * cardiac surgery with cardiopulmonary bypass (CPB) * New York Heart Association (NYHA) class I, II, III * preoperative serum creatinine less than 1.2 mg / dl Exclusion Criteria: * contraindications to Trans Esophageal Ultrasound (TEE) based on American Society of Anesthesiologists (ASA) recommendations (esophageal or gastric diseases or previous surgery) * history of non-coronary arterial pathologies * atrial fibrillation * preoperative serum creatinine greater than 1.2 mg / dl • NYHA class IV * emergency cardiac surgery

Primary outcome measure(s)

  • Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB) — Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe
    Right renal artery mean blood velocity (cm/sec) before CPB
  • Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB) — Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability
    Right renal artery mean blood velocity (cm/sec) before CPB
  • Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB) — CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
    Right renal artery mean blood velocity (cm/sec) during CPB
  • Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB) — CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
    Right renal artery mean blood velocity (cm/sec) during CPB
  • Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB) — CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
    Right renal artery mean blood velocity (cm/sec) during CPB

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A,Gemelli IRCCS Roma Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06009809 on ClinicalTrials.gov ↗ ← All trials in Italy