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

NCT06009809 | Recruiting

• 1 other identifier: 4708
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Surgical Procedure

Keywords

cardiopulmonary by-pass; transesophageal echocardiogram; acute kidney injury

Outcome Measures

Primary Outcomes (5)

• Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)

  Right renal artery mean blood velocity (cm/sec) before CPB

  Basal 1: up to 10 minutes after induction of anesthesia and placement of transesophageal probe

• Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)

  Right renal artery mean blood velocity (cm/sec) before CPB

  Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability

• Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)

  Right renal artery mean blood velocity (cm/sec) during CPB

  CPB 5 min: during CPB, 5 minutes after the end of the first cardioplegia

• Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)

  Right renal artery mean blood velocity (cm/sec) during CPB

  CPB 30 min: during CPB, 30 minutes after the end of the first cardioplegia

• Comparison of right renal artery mean blood velocities before and during cardiopulmonary by-pass (CPB)

  Right renal artery mean blood velocity (cm/sec) during CPB

  CPB 60 min: during CPB, 60 minutes after the end of the first cardioplegia

Secondary Outcomes (59)

• 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 probe

• Comparison of superior mesenteric artery mean blood velocities before and during cardiopulmonary by-pass (CPB)

  Basal 2: up to 30 minutes after sternotomy in conditions of hemodynamic stability

• Comparison of superior mesenteric 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

• Comparison of superior mesenteric 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

• Comparison of superior mesenteric 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

Study Arms (1)

Heart Surgical Patients

Patients with cardiovascular disease, who must undergo cardiac surgery in extracorporeal circulation with continuous flow

Diagnostic Test: transesophageal echocardiogram

Interventions

transesophageal echocardiogram DIAGNOSTIC_TEST

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

Heart Surgical Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will enroll patients of both sexes, aged\> 18 years, with cardiovascular disease, who must undergo cardiac surgery in extracorporeal circulation with continuous flow

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A,Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Echocardiography; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Cavaliere Franco, M.D.

  Fondazione Policlinico Agostino Gemelli IRRCS

  STUDY CHAIR

Central Study Contacts

Gabriella Arlotta, M.D.

CONTACT

+390630154848; g.arlotta72@gmail.com

Temistocle Taccheri, M.D.

CONTACT

+390630154848; taccheri.temistocle@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: August 24, 2023
• Study Start: February 15, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

IT (1)