Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
20 participants
INTERVENTIONAL
2018-02-21
2022-06-30
Brief Summary
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Detailed Description
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Researchers in the United States have safely performed contrast-enhanced ultrasounds of the kidney in healthy participants, and radiologists have used ultrasound contrast agents off-label to better visualize organs other than the heart when clinically indicated. In terms of kidney transplants, European data suggest CEUS of the allograft on post-operative day (POD) 7 is superior to DUS for predicting 12-month allograft function, but there are no published studies using CEUS on POD 1 to diagnose DGF or acute rejection.
The pathophysiology of both DGF and acute rejection involve interactions between the microvasculature, parenchymal cells and inflammatory cells, though with differences in timing and within different zones of the kidney itself. A very important feature of CEUS is its capacity to measure microvascular perfusion, whereas DUS can only estimate flow within larger vessels. This potential innovation for assessing the renal macro- and microvasculature may allow for earlier non-invasive detection of DGF and acute rejection. With additional research, it may ultimately be shown that non-invasive CEUS will revolutionize early DGF and acute rejection diagnosis to enable improvement in long-term patient and allograft survival.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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CEUS and Delayed Graft Function
On the first post-operative day after kidney transplantation, recipients enrolled in the study will undergo CEUS using Lumason to quantify microvascular perfusion within the cortical and medullary zones of the kidney allograft for comparison to the concentration of neutrophil gelatinase-associated lipocalin (NGAL, an early biomarker of acute kidney injury) measured from recipient urine simultaneously collected on the first post-operative day.
Lumason Contrast-Enhanced Ultrasound
In both arms, we will use Lumason to measure kidney allograft perfusion via contrast-enhanced ultrasound.
CEUS and Biopsy-Proven Acute Rejection
We will identify and enroll kidney transplant recipients in need of clinically-indicated duplex ultrasounds and possible biopsy to evaluate allograft dysfunction during hospital admissions and outpatient follow-up. Immediately after the duplex ultrasound, we will perform CEUS using Lumason for allograft perfusion measurements to determine its potential association with biopsy-proven acute rejection according to the most recent Banff criteria.
Lumason Contrast-Enhanced Ultrasound
In both arms, we will use Lumason to measure kidney allograft perfusion via contrast-enhanced ultrasound.
Interventions
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Lumason Contrast-Enhanced Ultrasound
In both arms, we will use Lumason to measure kidney allograft perfusion via contrast-enhanced ultrasound.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of non-renal transplant
* Uncontrolled diabetes or hypertension
* Symptomatic or significant pulmonary or cardiovascular disease
* Clinical decision by the treating team to forego the study procedure due to medical/surgical instability
18 Years
ALL
No
Sponsors
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National Kidney Foundation, United States
OTHER
American Heart Association
OTHER
National Center for Advancing Translational Sciences (NCATS)
NIH
University of Utah
OTHER
Responsible Party
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Principal Investigators
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Isaac E Hall, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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University of Utah Hospital
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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IRB_00092223
Identifier Type: -
Identifier Source: org_study_id