Fondazione Policlinico Universitario A,Gemelli IRCCS
Roma, 00168, Italy
Location status: Recruiting
Location contact
Gabriella Arlotta, MD
CONTACT
Temistocle Taccheri
CONTACT
NCT Number: NCT06009809
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.
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Request Info18 year and older
All sexes
Observational
Roma, 00168, Italy
Location status: Recruiting
Gabriella Arlotta, MD
CONTACT
Temistocle Taccheri
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To measure mean blood velocity at the level of the right renal and superior mesenteric artery
Time frame: 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
Time frame: Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability
Right renal artery mean blood velocity (cm/sec) before CPB
Time frame: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
Right renal artery mean blood velocity (cm/sec) during CPB
Time frame: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
Right renal artery mean blood velocity (cm/sec) during CPB
Time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Right renal artery mean blood velocity (cm/sec) during CPB
Time frame: Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe
Superior mesenteric artery mean blood velocity (cm/sec) before CPB
Time frame: Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability
Superior mesenteric artery mean blood velocity (cm/sec) before CPB
Time frame: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
Superior mesenteric artery mean blood velocity (cm/sec) during CPB
Time frame: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
Superior mesenteric artery mean blood velocity (cm/sec) during CPB
Time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Superior mesenteric artery mean blood velocity (cm/sec) during CPB
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity (cm/sec) and CPB blood flow (L/min)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity (cm/sec) and CPB blood flow (L/min)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia, during cardiopulmonary by-pass
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and cardiopulmonary by-pass blood flow (L/min)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and MAP (mmHg)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right arterial mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and MAP (mmHg)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and mean arterial pressure (mmHg)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and MAP (mmHg)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial PCO2 (mmHg)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and hematocrit
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and hematocrit
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and Temperature (Celsius degrees9
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity (cm/sec) and negative pressure applied to the venous drainage (vacuum-assist venous drainage) (mmHg)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and VAVD (mmHg)
Time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and VAVD (mmHg)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD) (mmHg)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and negative pressure applied to the venous drainage (vacuum-assist venous drainage, VAVD) (mmHg)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity values and VAVD (mmHg)
Time frame: CPB 5 min: 5 minutes after the end of the first cardioplegia, during CPB
Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Time frame: CPB 30 min: 30 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Time frame: CPB 60 min: 60 minutes after the end of the first cardioplegia
Correlation between right renal artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Time frame: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Time frame: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Correlation between superior mesenteric artery mean blood velocity (cm/sec) and arterial lactate (mmol/L)
Time frame: CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia
Comparison 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
Time frame: CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia
Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according KDIGO definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period
Time frame: CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia
Comparison between right renal artery mean blood velocity (cm/sec) measured during CPB in patients who develop AKI according KDIGO definition (AKI group) and in patients who don't develop AKI (non AKI group) during the postoperative period
Time frame: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
Comparison 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
Time frame: Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass
Comparison 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
Time frame: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
Comparison between urinary uNGAL mean level (ng/ml) measured on the first postoperative day 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
Time frame: Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass
Comparison 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
Time frame: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
Comparison 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
Time frame: Immediate postoperative period: 4 hours after the end of the cardiopulmonary by-pass
Comparison 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
Time frame: Postoperative day 1: 24 hours after the end of the cardiopulmonary by-pass
Comparison between mean serum amylase (UI/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 blood velocity (cm/sec) measured during CPB
Time frame: During CPB
the number of patients in whom is possible to measure right renal artery blood velocity during CPB
Time frame: During CPB
the number of patients in whom is possible to measure superior mesenteric artery blood velocity during CPB
Contact information is provided by the study sponsor or research team.
Gabriella Arlotta, M.D.
CONTACT
Temistocle Taccheri, M.D.
CONTACT
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
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