CE-US in Renal Transplantation

Phase 2

Completed

• Conditions: Renal Transplantation
• Interventions: Procedure: Contrast-enhanced ultrasound (CE-US); Device: SonoVue

• Registration Number: NCT01815320
• Lead Sponsor: Mario Negri Institute for Pharmacological Research

Brief Summary

Acute allograft dysfunction is often observed in the first weeks after kidney transplantation. Renal biopsy is universally considered the gold standard procedure for differential diagnosis of acute allograft dysfunction secondary to intraparenchymal causes. Kidney biopsy, however, is an invasive procedure that is time and cost consuming. Moreover, it may but not contribute to clinical diagnosis in about 10% of cases because of the impossibility to perform the analysis or of inadequacy of the biopsy sample. Availability or readily applicable non-invasive procedures might therefore allow increasing the performance of differential diagnosis of allograft dysfunction. In the recent years, a novel US imaging technique, namely contrast-enhanced ultrasound (CE-US),has been developed. The agent used in this study, Sonovue microbubbles consist of a central sulphur hexafluoride core with a surrounding phospholipid monolayer and last for several minutes in the systemic circulation before spontaneous degradation with absorption of the gaseous component by the lungs and the phospholipid shell by the liver. With the use of gasfilled microbubbles that act as scatterers within the blood stream and the development of low-MI ultrasound techniques that allow the visualization of the bubbles without destroying them, it is possible to improve the depiction of vessels and have access to structural and functional information on the microcirculation. Moreover SonoVue microbubbles are not nephrotoxic and can be safely used to evaluate kidney disfunction.

Thus, whether a. different patterns of parenchymal perfusion detected by CE-US can be associated with different patterns of renal graft involvement during acute renal function deterioration and b. whether, conversely, different patterns of parenchymal perfusion detected by CE-US may help predicting different patterns of renal involvement will be investigated in 20 deceased or living donor kidney graft recipients.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-10
• Study First Submitted: 2013-02-25
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-21
• Study Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Contrast-enhanced ultrasound (CE-US)	Contrast-enhanced ultrasound (CE-US)	Ce-US is performed by contrast agent infusion SonoVue. The acquisition protocol will consist of two different administrations of SonoVue, performed 10 minutes apart. In the first session, SonoVue microbubbles will be administered as a fast 1.5 ml bolus immediately followed by 5 ml saline solution. In the second session, max 2 vials (9.6 ml) of SonoVue will be infused at an infusion rate between 0.5 and 1.0 ml/min.
Contrast-enhanced ultrasound (CE-US)	SonoVue	Ce-US is performed by contrast agent infusion SonoVue. The acquisition protocol will consist of two different administrations of SonoVue, performed 10 minutes apart. In the first session, SonoVue microbubbles will be administered as a fast 1.5 ml bolus immediately followed by 5 ml saline solution. In the second session, max 2 vials (9.6 ml) of SonoVue will be infused at an infusion rate between 0.5 and 1.0 ml/min.

Primary Outcome Measures

Name	Time	Method
Changes in complete or partial occlusion of pre-glomerular arteries and arterioles;changes in functional (and reversible) vasoconstriction of pre-glomerular arteries and arterioles.	At week 1,2,3 and 4.	All examinations will be done by Contrast-enhanced ultrasound. Contrast agent wash-in (sec) and contrast agent wash-out (sec) will be assessed.
Changes in interstitial edema and cellular infiltration with tubulitis; changes in interstitial edema with tubular cell necrosis.	At month 2,3,4,5,6,7,8,9,10,11,and 12.	All examinations will be done by Contrast-enhanced ultrasound. Contrast agent wash-in (sec) and contrast agent wash-out (sec) will be assessed.
Changes in complete or partial occlusion of pre-glomerular arteries and arterioles; changes in functional (and reversible) vasoconstriction of pre-glomerular arteries and arterioles.	At month 2,3,4,5,6,7,8,9,10,11,and 12.	All examinations will be done by Contrast-enhanced ultrasound. Contrast agent wash-in (sec) and contrast agent wash-out (sec) will be assessed.

Secondary Outcome Measures

Name	Time	Method
Changes in CE-US parameters from episodes of acute allograft deterioration versus baseline	At the time of acute allograft episode, assessed up to 12 months.	All examinations will be done by Contrast-enhanced ultrasound. Contrast agent wash-in (sec) and contrast agent wash-out (sec) will be assessed.

Trial Locations

Locations (1)

Unità di Nefrologia e Dialisi - A.O. Papa Giovanni XXIII; 🇮🇹 Bergamo, Italy