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Completed

NCT Number: NCT01815320

CE-US in Renal Transplantation

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Unità di Nefrologia e Dialisi - A.O. Papa Giovanni XXIII

Bergamo, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Kidney transplantation with a functioning graft (dialysis independence)
  • Clinical indication to histologic evaluation of the kidney graft
  • Written Informed consent (according to the Declaration of Helsinki guidelines)

Exclusion criteria

  • Specific contraindications to histologic evaluation of the kidney graft (bleeding time > 15 min, intra-abdominal implantation of the graft)
  • Known hypersensitivity to sulphur hexafluoride or to any of the components of SonoVue.
  • Recent Acute Coronary Syndrome (ACS) or clinically unstable ischaemic cardiac disease, including: evolving or ongoing myocardial infarction, typical angina at rest within last 7 days, significant worsening of cardiac symptoms within last 7 days, recent coronar artery intervention or other factors suggesting clinical instability (for example, recent deterioration of ECG, laboratory or clinical findings), acute cardiac failure, Class III/IV cardiac failure, or severe rhythm disorders.
  • Right-to-left shunts, severe pulmonary hypertension (PAP >90 mmHg

Treatment and study plan

Contrast-enhanced ultrasound (CE-US)

Procedure

SonoVue

Device

Primary outcomes

  1. Changes in complete or partial occlusion of pre-glomerular arteries and arterioles;changes in functional (and reversible) vasoconstriction of pre-glomerular arteries and arterioles.

    Time frame: 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.

  2. Changes in interstitial edema and cellular infiltration with tubulitis; changes in interstitial edema with tubular cell necrosis.

    Time frame: 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.

  3. Changes in complete or partial occlusion of pre-glomerular arteries and arterioles; changes in functional (and reversible) vasoconstriction of pre-glomerular arteries and arterioles.

    Time frame: 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.

  4. Changes in interstitial edema and cellular infiltration with tubulitis; changes in interstitial edema with tubular cell necrosis.

    Time frame: 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 outcomes

  1. Changes in CE-US parameters from episodes of acute allograft deterioration versus baseline

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Registry information

Official study title

A PILOT, EXPLORATIVE STUDY TO IDENTIFY CONTRAST-ENHANCED ULTRASOUND (CE-US) PATTERNS THAT CHARACTERIZE ACUTE ALLOGRAFT REJECTION AND OTHER CAUSES OF ACUTE ALLOGRAFT DYSFUNCTION IN RENAL TRANSPLANT RECIPIENTS

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Mar 21, 2013
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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