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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06009809
Enrollment
92
Registered
2023-08-24
Start date
2022-02-15
Completion date
2025-12-31
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Surgical Procedure

Keywords

cardiopulmonary by-pass, transesophageal echocardiogram, acute kidney injury

Brief 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.

Detailed description

The cardiopulmonary by-pass (CPB) 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 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 (RRT) in the postoperative period presenting a mortality that can reach 50-70%. However, even more limited increases in serum creatinine (sCr) are associated with worsening prognosis and the risk of chronic kidney disease (CKD). The pathophysiology of AKI in cardiac surgery is complex and still partly unknown. It is believed that one of the main causative factors is hypoperfusion and renal hypoxia, in particular of the medullary region; this would result in a vasoconstriction of the afferent arterioles to the glomerulus and a reduction in filtration. Risk factors associated with the increased incidence of AKI include bleeding, use of the aortic pump, excessive cardiopulmonary bypass duration, excessive haemodilution, insufficient pump flow, or insufficient blood pressure. Hypothermia, which also has a protective effect against hypoperfusion and tissue hypoxia, could induce AKI by increasing renal vascular resistance and favoring medullary hypoxia during subsequent rewarming. In addition to AKI, another complication of cardiac surgery, rarer but associated with a higher mortality, is acute mesenteric ischemia; the most frequent type is non-occlusive mesenteric ischemia (NOMI) which seems to have as a predisposing cause a reduction or maldistribution of splanchnic blood flow and the use of vasoconstrictors. 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. The calculation of these indices, however, requires the use of a pulsatile blood flow to generate a periodic variation of the blood velocity, and they are not evaluable during CPB since the current practice in almost all centers is to use a continuous blood flow. 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 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.

Interventions

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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
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 probeRight renal artery mean blood velocity (cm/sec) before CPB

Secondary

MeasureTime frameDescription
Correlation between mean blood velocity values and hemodynamic parameters: cardiopulmonary by-pass (CPB) blood flowCPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between right renal artery mean blood velocity (cm/sec) and CPB blood flow (L/min)
Correlation between mean blood velocity values and CPB blood flowCPB 30 min: 30 minutes after the end of the first cardioplegia, during CPBCorrelation between right renal artery mean blood velocity (cm/sec) and CPB blood flow (L/min)
Correlation between right renal artery mean blood velocity values and CPB blood flowCPB 60 min: 60 minutes after the end of the first cardioplegiaCorrelation between right renal artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Correlation between superior mesenteric artery mean blood velocity values and cardiopulmonary by-pass (CPB) blood flowCPB 5 min: 5 minutes after the end of the first cardioplegiaCorrelation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Correlation between superior mesenteric artery mean blood velocity values and CPB blood flowCPB 30 min: 30 minutes after the end of the first cardioplegia, during cardiopulmonary by-passCorrelation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Correlation between right renal artery mean blood velocity values and hemodynamic parameters (mean arterial pressure, MAP)CPB 5 min: 5 minutes after the end of the first cardioplegiaCorrelation between right renal artery mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
Correlation between right renal artery mean blood velocity values and MAPCPB 30 min: 30 minutes after the end of the first cardioplegiaCorrelation between right renal artery mean blood velocity (cm/sec) and MAP (mmHg)
Correlation between superior mesenteric artery mean blood velocity values and hemodynamic parameters (mean arterial pressure, MAP)CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between superior mesenteric artery mean blood velocity (cm/sec) and MAP (mmHg)
Correlation between superior mesenteric artery mean blood velocity values and MAPCPB 30 min: 30 minutes after the end of the first cardioplegiaCorrelation between superior mesenteric artery mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial PCO2)CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Correlation between right renal artery mean blood velocity values and arterial PCO2CPB 60 min: 60 minutes after the end of the first cardioplegiaCorrelation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Correlation between superior mesenteric artery mean blood velocity values and laboratory parameters (arterial PCO2)CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Correlation between superior mesenteric artery mean blood velocity values and arterial PCO2CPB 60 min: 60 minutes after the end of the first cardioplegiaCorrelation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Correlation between right renal artery mean mean blood velocity values and laboratory parameters (Hematocrit)CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between right renal artery mean blood velocity (cm/sec) and hematocrit
Correlation between superior mesenteric artery mean mean blood velocity values and laboratory parameters (Hematocrit)CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit
Comparison of superior mesenteric 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 probeSuperior mesenteric artery mean blood velocity (cm/sec) before CPB
Correlation between right renal artery mean blood velocity values and TemperatureCPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Correlation between superior mesenteric artery mean blood velocity values and TemperatureCPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Correlation between right renal artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between right renal artery mean blood velocity (cm/sec) and negative pressure applied to the venous drainage (vacuum-assist venous drainage) (mmHg)
Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD)CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD) (mmHg)
Correlation between right renal artery mean blood velocity values and laboratory parameters (arterial lactate)CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPBCorrelation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Correlation between superior mesenteric artery mean blood velocity and laboratory parameters (arterial lactate)CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegiaCorrelation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Correlation between right renal artery mean blood velocity values during CPB and Acute Kidney Injury (AKI)CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegiaComparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according Kidney Disease Improving Global Outcomes (KDIGO) definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period
Evaluation of serum Cystatin C in low right renal artery mean blood velocity during CPBPostoperative day 1: 24 hours after the end of the cardiopulmonary by-passComparison between serum Cystatin C mean level (mg/L) measured in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) measured during CPB
Evaluation of urinary Neutrophil Gelatinase-associated Lipocalin (uNGAL) in low right renal artery mean blood velocityImmediate postoperative period: 4 hours after the end of the cardiopulmonary by-passComparison between urinary uNGAL mean level (ng/ml) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) right renal artery blood velocity (cm/sec) during CPB
Evaluation of lactate in patients with low superior mesenteric artery mean blood velocity valuesImmediate postoperative period: 4 hours after the end of the cardiopulmonary by-passComparison between mean arterial lactate (mmol/L) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) during CPB
Evaluation of lactate in patients with low superior mesenteric artery mean blood velocityPostoperative day 1: 24 hours after the end of the cardiopulmonary by-passComparison between arterial lactate (mmol/L) measured on the first postoperative day in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery mean blood velocity (cm/sec) measured during CPB
Evaluation of amylase in low superior mesenteric artery mean blood velocityImmediate postoperative period: 4 hours after the end of the cardiopulmonary by-passComparison between mean serum amylase (UI/L) measured immediately after surgery in patients with low (below the 25th percentile) and in patients with higher (above 25th percentile) superior mesenteric artery blood velocity (cm/sec) measured during CPB
Feasibility of measurement of right renal artery blood velocity during CPBDuring CPBthe number of patients in whom is possible to measure right renal artery blood velocity during CPB
Feasibility of measurement of superior mesenteric artery blood velocity during CPBDuring CPBthe number of patients in whom is possible to measure superior mesenteric artery blood velocity during CPB
Correlation between superior mesenteric artery mean mean blood velocity values and HematocritCPB 30 min: 30 minutes after the end of the first cardioplegiaCorrelation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit

Countries

Italy

Contacts

Primary ContactGabriella Arlotta, M.D.
g.arlotta72@gmail.com+390630154848
Backup ContactTemistocle Taccheri, M.D.
taccheri.temistocle@gmail.com+390630154848

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026